throbber
Shoulder Arthroscopy
`
`BIORAPTOR™ CURVED
`OSTEORAPTOR™ CURVED
`Suture Anchors and Guide System
`
`• Curved Drill Guides with a 25°
`bend improve the trajectory of
`drilling and optimize anchor
`placement in the glenoid1
`
`• Internal structures are better
`protected, as the Curved Drill
`Guides angle the Flexible Twist
`Drill and anchor into bone and
`away from the surface1
`
`1 Data on file at Smith & Nephew,
`ITR-15001065, 2011
`
`SPIDER2
`Limb Positioner
`
`• Advanced Sterile Drape features
`integrated patient positioning
`switch
`
`• Distal activation switch eliminates
`the need for a foot pedal
`
`• Rechargeable Battery
`eliminates the inconvenience
`of a power cord
`
`Arthrex Exhibit 2003
`Smith & Nephew v. Arthrex
`IPR2016-00507
`
`Arthrex Exhibit 2003 - Page 1
`
`

`
`B-1
`
`Rotator Cuff Soft Tissue Fixation
`HEALICOIL™ PK Suture Anchors (non-absorbable)
`HEALICOIL PK Suture Anchors
`The unique open-architecture design of the HEALICOIL PK Suture Anchor utilizes significantly
`less material than standard solid-core anchors, dramatically minimizing the volume of
`material implanted in the shoulder. The HEALICOIL PK anchor inserts easily into all densities
`of humeral bone. Torque is distributed along the length of the anchor during insertion and
`improved anchor thread engagement in the bone delivers superior pullout strength.
`
`The HEALICOIL PK Suture Anchors can be used for primary or double row repairs and in the
`medial row of a suture bridging technique.
`
`Non-absorbable
`Our non-absorbable PK suture anchors incorporate PEEK-OPTIMA® polymer from Invibio®.
`PEEK-OPTIMA material provides an ideal combination of strength, biocompatibility, revisability
`and inherent radiolucent characteristics.
`
`Reference #
`72203378
`
`72203379
`
`72203380
`
`Instruments
`72202621
`
`72201915
`
`72203335
`
`72203336
`
`72203482
`72203483
`
`Description
` 4.5 mm HEALICOIL PK Suture Anchor with two ULTRABRAID™ (#2) Sutures
`(blue, blue-COBRAID), sterile
` 5.5 mm HEALICOIL PK Suture Anchor with Two ULTRABRAID (#2) Sutures
`(blue, blue-COBRAID), sterile
` 5.5 mm HEALICOIL PK Suture Anchor with Three ULTRABRAID (#2) Sutures
`(blue, blue-COBRAID, COBRAID-black), sterile
`
` 3.8 mm Tapered Awl, disposable
`(general hole preparation for normal bone quality)
` 3.8 mm Tapered Awl, reusable
`(general hole preparation for normal bone quality)
` 4.5 mm HEALICOIL Awl Dilator, reusable
`(hole preparation for normal and hard bone quality)
` 5.5 mm HEALICOIL Awl Dilator, reusable
`(hole preparation for normal and hard bone quality)
`3.5 mm HEALICOIL Spade Tip Drill for use with 4.5 mm HEALICOIL Suture Anchor
`4.5 mm HEALICOIL Spade Tip Drill for use with 5.5 mm HEALICOIL Suture Anchor
`
`Arthrex Exhibit 2003 - Page 2
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-2
`
`Rotator Cuff Soft Tissue Fixation
`TWINFIX™ Ultra HA Suture Anchors
`TWINFIX Ultra HA Suture Anchors
`Available in a variety of size options with a choice of suture configurations, TWINFIX Ultra
`Suture Anchors can be used for primary or double row repairs and for the medial row of a
`suture bridging technique.
`
`Absorbable
`Our absorbable HA suture anchor combines poly-l-lactic acid (PLLA) with hydroxyapatite
`(HA), a calcium phosphate similar to the mineral compound of bone. Once absorbed, it
`has the fracture resistance of human cortical bone.* HA is a natural bone mineral shown to
`promote bone replacement.†
`
`Reference #
`72202597
`
`72202624
`
`72202602
`
`72202626
`
`72202603
`
`72202608
`
`72202631
`
`72202610
`
`
`Instruments
`72202633
`72202634
`72202116
`
`72201707
`
`72201708
`
`Description
` 4.5 mm TWINFIX Ultra HA Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 4.5 mm TWINFIX Ultra HA Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX Ultra HA Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 5.5 mm TWINFIX Ultra HA Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX Ultra HA Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black)
` 6.5 mm TWINFIX Ultra HA Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 6.5 mm TWINFIX Ultra HA Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 6.5 mm TWINFIX Ultra HA Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
`
` 4.5 Awl Dilator for use with 4.5 mm anchor hole preparation
` 5.5/6.5 Awl Dilator for use with 6.5 mm anchor hole preparation
` 3.5 mm Spade Tip Drill for use with 4.5 mm anchor hole preparation
`device for hard bone
` 4.5 mm Spade Tip Drill for use with 5.5 mm anchor hole preparation
`device for hard bone
` 5.5 mm Spade Tip Drill for use with 6.5 mm anchor hole preparation
`device for hard bone
`
`* Akao, M., Aoki, H. and Kato, K., Mechanical properties of sintered hydroxyapatite for prosthetic
`applications. Journal of Material Science: 16, 809–812, (1981).
`† S.D. Cook, D.A. Funk, T.P. Schmalzried. Orthopedic Biomaterials and Implant Fixation, instructional
`course lecture, AAOS 63rd meeting.
`
`Arthrex Exhibit 2003 - Page 3
`
`Shoulder Arthroscopy
`
`

`
`B-3
`
`Rotator Cuff Soft Tissue Fixation
`TWINFIX™ Ultra PK Suture Anchors
`TWINFIX Ultra PK Suture Anchors
`Available in a variety of size options with a choice of suture configurations, TWINFIX Ultra
`Suture Anchors can be used for primary or double row repairs and for the medial row of a
`suture bridging technique.
`
`Non-absorbable
`Our non-absorbable PK suture anchor incorporates PEEK-OPTIMA® polymer from Invibio®.
`With a modulus similar to cortical bone, PEEK-OPTIMA exhibits an ideal combination of
`strength, biocompatibility, revisability and inherent radiolucent characteristics.
`
`Reference #
`72202595
`
`72202623
`
`72203103
`
`72202599
`
`72202625
`
`72202600
`
`72203104
`
`72202605
`
`72202630
`
`72202606
`
`72203105
`
`Instruments
`72202621
`
`72201915
`
`72202633
`
`72202634
`
`72202116
`
`72201707
`
`72201708
`
`Description
` 4.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 4.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 4.5 mm TWINFIX Ultra Anchor with two #2 sutures
`(blue, blue-COBRAID), sterile
` 4.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 5.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX Ultra PK Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(blue, blue-COBRAID), sterile
` 6.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 6.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 6.5 mm TWINFIX Ultra PK Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
` 6.5 mm TWINFIX Ultra PK Anchor with two #2 sutures
`(blue, blue-COBRAID), sterile
`
` 3.8 Tapered Awl – Disposable for use with general hole
`preparation for normal bone quality
` 3.8 Tapered Awl – Reusable for use with general hole
`preparation for normal bone quality
` 4.5 Awl – Dilator for use with 4.5 mm anchor hole
`preparation for hard bone
` 5.5/6.5 Awl – Dilator for use with 5.5/6.5 mm anchor hole
`preparation for hard bone
` 3.5 mm Spade Tip Drill for use with 4.5 mm anchor hole
`preparation for hard bone
` 4.5 mm Spade Tip Drill for use with 5.5 mm anchor hole
`preparation for hard bone
` 5.5 mm Spade Tip Drill for use with 6.5 mm anchor hole
`preparation for hard bone
`
`Call +1-800-343-5717 (U.S.) or contact your local representative.
`
`Arthrex Exhibit 2003 - Page 4
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-4
`
`Rotator Cuff Soft Tissue Fixation
`TWINFIX™ Ultra Ti Suture Anchors
`TWINFIX Ultra Ti Suture Anchors
`Available in a variety of size options with a choice of suture configurations, TWINFIX Ultra
`Suture Anchors can be used for primary or double row repairs and for the medial row of a
`suture bridging technique.
`
`Non-absorbable
`Titanium (Ti) suture anchors exhibit ideal fixation strength and anchor stability.
`Elongated distal trocar tips allow anchors to be self-tapping; without the need to
`predrill in most bone qualities.
`
`Reference #
`72202893
`
`72202894
`
`72202895
`
`72202896
`
`72202897
`
`72202898
`
`72202899
`
`72202900
`
`Instruments:
`72202116
`
`72201707
`
`72201708
`
`72202621
`72201915
`
`Description
` 4.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 4.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
` 6.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures
`(white, COBRAID-blue), sterile
` 6.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), sterile
` 6.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
`
` 3.5 mm Spade Tip Drill for use with 4.5 mm anchor hole
`preparation device for hard bone
` 4.5 mm Spade Tip Drill for use with 5.5 mm anchor hole
`preparation device for hard bone
` 5.5 mm Spade Tip Drill for use with 6.5 mm anchor hole
`preparation device for hard bone
`3.8 mm Tapered Awl-Disposable
`3.8 mm Tapered Awl-Reusable
`
`* Item shown
`
`Arthrex Exhibit 2003 - Page 5
`
`Shoulder Arthroscopy
`
`

`
`Rotator Cuff Soft Tissue Fixation
`TWINFIX™ Ultra Suture Anchors with Needles
`Easy-to-use handles for speed and efficiency. TWINFIX Ultra Preloaded Suture Anchors
`with Needles combine best-in-class anchor pullout strength* with controlled suture
`and needle management for your mini-open rotator cuff repairs.
`
`B-5
`
`Trusted anchor material choices include
`absorbable (HA), non-absorbable (PK) and
`metallic (Ti) materials.
`
`Ergonomically designed
`handles with twist-and-release
`needle delivery system.
`
`Preloaded and ready-to-use
`needles in handle.
`
`After placing anchor in the bone,
`please follow the steps below:
`
`Increased visiblity; preloaded blue
`suture brings reliable suture fixation with
`low knot profile.
`
`Secure fixation is achieved with a transitional thread
`design. Distal “cutting” threads provide easy insertion and
`proximal “locking” threads provide strong pullout strength,
`even in poor bone quality.*
`
`Description
` 4.5 mm TWINFIX Ultra PK Suture Anchor with
`two #2 ULTRABRAID™ Sutures (blue, blue-COBRAID) with Needles
` 5.5 mm TWINFIX Ultra PK Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 6.5 mm TWINFIX Ultra PK Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 4.5 mm TWINFIX Ultra PLLA-HA Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 5.5 mm TWINFIX Ultra PLLA-HA Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 6.5 mm TWINFIX Ultra PLLA-HA Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 4.5 mm TWINFIX Ultra Ti Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 5.5 mm TWINFIX Ultra Ti Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
` 6.5 mm TWINFIX Ultra Ti Suture Anchor with
`two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
`
`Reference #
`72202611
`
`72202615
`
`72202619
`
`72202612
`
`72202616
`
`72202620
`
`72202613
`
`72202618
`
`72202622
`
`* Data on file at Smith & Nephew 2009, ITR-4091, ITR-4039, ITR-3952.
`
`Step 1 – Ready
`
`Step 2 – Twist
`
`Step 3 – Full Turn
`
`Arthrex Exhibit 2003 - Page 6
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-6
`
`Rotator Cuff Soft Tissue Fixation – Absorbable Polymer Anchors
`TWINFIX™ AB 5.0 and TWINFIX AB 6.5 Suture Anchors
`The unique thread design of the TWINFIX AB anchors provides extraordinary pullout strength
`and easy insertion in all bone conditions, and provides superior solutions to the orthopaedic
`surgeon. The absorbable material is time tested and proven PLLA.
`
`72200786
`
`7210309
`
`7210304
`
`TWINFIX AB 5.0 and TWINFIX AB 6.5 with DURABRAID™ Suture
`Reference #
`Description
`72200785
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures, sterile
`
` 5.0 mm TWINFIX AB Suture Anchor,
`PLLA, with two #2 preloaded DURABRAID sutures
`packaged with threaded dilator, sterile
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures with needles, sterile
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures with needles,
`packaged with threaded dilator, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures, packaged
`with threaded dilator, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures with needles, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded DURABRAID sutures with needles,
`packaged with threaded dilator, sterile
`
`72200787
`
`72200788
`
`7210211
`
`7210212
`
`Accessories
`Reference #
`7209946
`7210819
`72201178*
`72200819
`72200820
`
`Description
`5.0 mm TWINFIX AB threaded dilator, reusable
`6.5 mm TWINFIX AB threaded dilator, reusable
` 5.0 mm TWINFIX AB Awl/threaded dilator, reusable
` 5.0 mm TWINFIX AB Suture Anchor threaded dilator, sterile
` 6.5 mm TWINFIX AB Suture Anchor threaded dilator, sterile
`
`AB – Absorable material
`PLLA – Poly L Lactic acid
`
`* Item shown
`
`Arthrex Exhibit 2003 - Page 7
`
`Shoulder Arthroscopy
`
`

`
`Rotator Cuff Soft Tissue Fixation – Absorbable Polymer Anchors
`TWINFIX™ AB 5.0 and TWINFIX AB 6.5 Suture Anchors
`TWINFIX AB 5.0 and TWINFIX AB 6.5 with ULTRABRAID™ Suture
`
`B-7
`
`Reference #
`72200777
`
`7210710
`
`72200778
`
`7210711
`
`72200688‡
`
`72200789‡
`
`72200779
`
`7210712
`
`72200780
`
`7210713
`
`Accessories
`Reference #
`7209946
`7210819
`72201178*
`72200819
`72200820
`
`Description
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures†, sterile
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures† with needles, sterile
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures†, packaged with
`threaded dilator, sterile
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures† with needles,
`packaged with threaded dilator, sterile
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures†, packaged (3 per box)
`withone threaded dilator, sterile, Suture Anchor Pack
` 5.0 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures†, packaged with
`one threaded dilator, sterile, no needles (5 per box)
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures†, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures† with needles, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures†, packaged with
`threaded dilator, sterile
` 6.5 mm TWINFIX AB Suture Anchor, PLLA, with two
`#2 preloaded ULTRABRAID sutures† with needles,
`packaged with threaded dilator, sterile
`
`Description
`5.0 mm TWINFIX AB threaded dilator, reusable
`6.5 mm TWINFIX AB threaded dilator, reusable
` 5.0 mm TWINFIX AB Awl/threaded dilator, reusable
` 5.0 mm TWINFIX AB Suture Anchor threaded dilator, sterile
` 6.5 mm TWINFIX AB Suture Anchor threaded dilator, sterile
`
`AB – Absorable material
`PLLA – Poly L Lactic acid
`
`* Item shown
`† One ULTRABRAID white suture and one ULTRABRAID COBRAID suture
`‡ US only
`
`Arthrex Exhibit 2003 - Page 8
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-8
`
`Rotator Cuff Soft Tissue Fixation – Non-absorbable Polymer Anchors
`TWINFIX™ PK FT Suture Anchors
`TWINFIX PK FT Suture Anchors
`The TWINFIX PK FT anchor is a fully threaded combination tap-in/screw-in anchor designed
`for rotator cuff repair. Made with radiolucent high strength PEEK-OPTIMA® polymer from
`Invibio®, the anchor has versions loaded with two or three ULTRABRAID™ sutures. An awl is
`used for hole preparation, and a drill is also available for use with hard bone applications.
`
`Reference #
`72201576
`
`72201578
`
`72201681
`
`72201683
`
`72201577
`
`72201579
`
`72201682
`
`72201684
`
`72201450
`72201707
`72201708
`72200867
`72202456
`
`72202457
`
`72202458
`
`Description
` 5.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, white ULTRABRAID), sterile
` 5.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, white ULTRABRAID), sterile, with awl
` 6.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, white ULTRABRAID), sterile
` 6.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, white ULTRABRAID), sterile, with awl
` 5.5 mm TWINFIX PK FT Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
` 5.5 mm TWINFIX PK FT Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile, with awl
` 6.5 mm TWINFIX PK FT Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile
` 6.5 mm TWINFIX PK FT Anchor with three #2 sutures
`(white, COBRAID-blue, COBRAID-black), sterile, with awl
` 3.8 mm Straight Awl, reusable
`Drill, 4.5 mm for use with the 5.5 PK FT anchor in hard bone
`Drill, 5.5 mm for use with the 6.5 PK FT anchor in hard bone
`Mallet with nylon ends
` 5.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black)
` 5.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black), with awl
` 6.5 mm TWINFIX PK FT Anchor with two #2 sutures
`(COBRAID-blue, COBRAID-black)
`
`Arthrex Exhibit 2003 - Page 9
`
`Shoulder Arthroscopy
`
`

`
`B-9
`
`Rotator Cuff Soft Tissue Fixation – Metallic Anchors
`TWINFIX™ Ti 5.0 and TWINFIX Ti 6.5 Suture Anchors
`TWINFIX Ti Suture Anchors
`The unique thread design of the TWINFIX Ti anchors provides extraordinary pullout
`strength and easy insertion in all bone conditions, and provides superior solutions to the
`orthopaedic surgeon.
`
`To offer the surgeon flexibility, depending on personal preference and patient profile,
`TWINFIX anchors are available with DURABRAID™ and ULTRABRAID™ suture. ULTRABRAID is
`constructed from UHMW (ultra-high molecular weight polyethylene) and possesses a unique
`and proprietary braid configuration. This provides ULTRABRAID with its extraordinary strength
`properties while contributing to its superior handling qualities.
`
`7210300
`
`TWINFIX Ti 5.0 and TWINFIX Ti 6.5 with DURABRAID Suture
`Reference #
`Description
`72200766
` 5.0 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded DURABRAID sutures, sterile
` 5.0 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded DURABRAID sutures with needles, sterile
` 6.5 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded DURABRAID sutures, sterile
` 6.5 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded DURABRAID sutures with needles, sterile
`
`72200769
`
`7210214
`
`7210708
`
`TWINFIX Ti 5.0 and TWINFIX Ti 6.5 with ULTRABAID Suture
`Reference #
`Description
`72200755
` 5.0 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded ULTRABRAID sutures*, sterile
` 5.0 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded ULTRABRAID sutures* with needles, sterile
` 6.5 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded ULTRABRAID sutures*, sterile
` 6.5 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded ULTRABRAID sutures* with needles , sterile
` 5.0 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded ULTRABRAID sutures*, sterile, Suture Anchor Pack (3 per box)
` 5.0 mm TWINFIX Ti Suture Anchor with two
`#2 preloaded ULTRABRAID sutures*, sterile, no needles (5 per box)
`
`72200758
`
`7210709
`
`72200687
`
`72200759
`
`TWINFIX Ti 5.0 and TWINFIX Ti 6.5 Instruments
`Reference #
`
`
`Description
`7210269
`6" Drill Guide – 6" x 6.5 mm Spiked Tip for 6.5 mm TWINFIX Ti anchor
`7209115
`6" Drill Guide – 6" x 5 mm Spiked Tip for 5.0 mm TWINFIX Ti anchor
`7209502
`2.5 mm Drill for TWINFIX Ti 3.5 mm and 5.0 mm anchor
`7210215
`3.5 mm Drill for TWINFIX Ti 6.5 mm anchor
`72201406
`12" Suture Passer, sterile
`72201407
`2" Suture Passer, sterile
`
`* One ULTRABRAID white suture and one ULTRABRAID COBRAID suture
`
`Arthrex Exhibit 2003 - Page 10
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-10
`
`Rotator Cuff Soft Tissue Fixation – Metallic Anchors
`TWINFIX Ti QUICK-T Fixation System
`TWINFIX Ti QUICK-T Fixation System
`The TWINFIX TI QUICK-T Fixation System provides a single-step tissue repair method
`that can be used for primary or secondary tissue fixation. This through-tendon technique
`combines the proven TWINFIX TI Soft Tissue Anchor with pre-tied knot technology, coupling
`the anchor with a high strength “T” bar made of PEEK-OPTIMA® LT3 polymer from Invibio®.
`The result is a secure, adjustable fixation system that can be used wherever a larger tissue
`footprint is needed.
`
`The QUICK-T System gives surgeons the unique ability to arthroscopically perform high
`strength, multi-row repairs more closely resembling those found in open or mini-open
`procedures. The low profile “T” component is delivered through the standard anchor delivery
`system, eliminating the need for special cannulae, and the “T” provides a 10 mm tissue
`bridge once it’s deployed and secured to the tissue surface.
`
`The QUICK-T System is also an excellent solution for biceps tenodesis and non-retracted and
`isolated supraspinatus tear repairs. Using the QUICK-T increases the tissue-to-bone contact
`area, recreating the natural footprint of the rotator cuff.
`
`Reference #
`72200767
`72200764
`7210116
`7209417
`72200768
`
`72200765
`
`7209114
`7209502
`
`Description
`5.0 mm TWINFIX Ti QUICK-T Fixation System, sterile
`3.5 mm TWINFIX Ti QUICK-T Fixation System, sterile
`ELITE Premium KNOT MANIPULATOR, QUICK-T, reusable, black loop
`TWINFIX QUICK-T Knot Pusher and Suture Cutter, sterile, disposable
` 5.0 mm TWINFIX QUICK-T implant with QUICK-T Knot Pusher and
`Suture Cutter, sterile
` 3.5 mm TWINFIX QUICK-T implant with QUICK-T Knot Pusher and
`Suture Cutter, sterile
`Drill guide, 5" x 4.0 mm, for use with 3.5 mm QUICK-T device
` Drill, 2.5 mm for TWINFIX Ti 3.5 mm and 5.0 mm anchors, suitable for
`Quick-T Systems
`
`Ti – Titanium
`
`Arthrex Exhibit 2003 - Page 11
`
`Shoulder Arthroscopy
`
`

`
`B-11
`
`Rotator Cuff Soft Tissue Fixation – Metallic Anchors
`Individually Packaged Anchors and Accessories
`Individually packaged anchors
`Anchors packaged without sutures or needles
`
`Reference #
`7209107
`7209108
`7209105
`7209109
`
`Accessories
`72201406
`72201407
`7209119
`7209120
`7209121
`7209165
`7209111
`
`Description
`2.8 mm TWINFIX™ Ti single anchor, sterile
`4.0 mm TWINFIX Ti single anchor, sterile
`5.0 mm TWINFIX Ti single anchor, sterile
`6.5 mm TWINFIX Ti single anchor, sterile
`
` 12" Suture Passer, single use, sterile
`2" Suture Passer, single use, sterile
`Inserter, TWINFIX Ti 4.0 mm and 6.5 mm, cannulated
`Inserter Shaft, TWINFIX Ti 2.8 mm, short 3", working length
`Inserter Shaft, TWINFIX Ti 2.8 mm, short 6", working length
`2.5 mm Drill for TWINFIX 4.0 mm, 5.0 mm, and 6.5 mm anchors
`6.5 mm Drill Guide, Spiked Tip
`
`Arthrex Exhibit 2003 - Page 12
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-12
`
`Rotator Cuff Soft Tissue Fixation
`FOOTPRINT Ultra PK Suture Anchor
`FOOTPRINT Ultra PK Suture Anchor
`Available in two sizes, 4.5 mm and 5.5 mm, the FOOTPRINT Ultra PK anchor is intended
`for use in the lateral row in double row suture bridging techniques.
`
`• Uniquely designed, inner plug adjustability means more precise fixation and suture
`tensioning of final repair
`• Reduced suture slippage means less gap formation and rotator cuff displacement*
`• Exclusive tap-in anchor design with offset barbed geometry threads means high pullout
`strength and easy insertion*
`
`Reference #
`72202901
`72202902
`
`Instruments
`72202621
`72201915
`72202116
`
`72201707
`
`72201450
`72202986
`
`Description
`4.5 mm FOOTPRINT Ultra Suture Anchor
`5.5 mm FOOTPRINT Ultra Suture Anchor
`
`3.8 mm Tapered Awl-Disposable
`3.8 mm Tapered Awl-Reusable
` 3.5 mm Spade Tip Drill for use with the 4.5 mm anchor
`hole preparation device for hard bone
` 4.5 mm Spade Tip Drill for use with the 5.5 mm anchor
`hole preparation device for hard bone
`3.8 mm Straight Awl-Reusable
`3.8 mm Straight Awl-Disposable
`
`* Data on file at Smith & Nephew,
` ITR-3679, 2008
`
`Special, Made to Order products are available to meet the individual needs of surgeons. Please appreciate that longer lead
`time for delivery should be expected. For more information, please contact your sales representative or Customer Service.
`
`Arthrex Exhibit 2003 - Page 13
`
`Shoulder Arthroscopy
`
`

`
`Rotator Cuff Soft Tissue Fixation – Non-absorbable Polymer Anchors
`FOOTPRINT PK Suture Anchor
`
`B-13
`
`FOOTPRINT PK Suture Anchor
`The FOOTPRINT PK Suture Anchor consists of a non-absorbable polymer (PEEK-OPTIMA®
`polymer from Invibio®). The sizes include a 5.5 mm anchor, and a back-up size of 6.5 mm.
`The anchor is composed of two parts, the “outer shell” and the “inner plug.” The design
`allows the anchor to be tapped in. Then, independent of implantation, the inner plug is
`screwed down, securing the medial anchor suture limbs that have been captured in
`the nose of the anchor.
`
`The FOOTPRINT PK Suture Anchor offers a rotator cuff repair technique that allows the
`surgeon to precisely apply the desired amount of suture tension that is appropriate and
`customized for each patient. The suture tension can be adjusted even after the anchor is
`implanted, unlike any competitive product on the market.
`
`Reference #
`72201697
`72201825
`72201698
`72201826
`
`Instruments
`72201450
`
`72201915
`72200867
`72200879
`72201707
`
`72201708
`
`72201899
`
`Description
`5.5 mm FOOTPRINT PK Suture Anchor
`5.5 mm FOOTPRINT PK Suture Anchor with disposable awl
`6.5 mm FOOTPRINT PK Suture Anchor
`6.5 mm FOOTPRINT PK Suture Anchor with disposable awl
`
` 3.8 mm Straight Awl for use with FOOTPRINT PK,
`TWINFIX™ PK FT and KINSA™ RC Anchors, reusable
`3.8 mm Tapered Awl, reusable (gold awl)
`Mallet with nylon ends
`Replacement end caps for mallet (set of 2)
` Spade Drill, 4.5 mm for use in hard bone with the
`FOOTPRINT PK 5.5 mm anchor and the TWINFIX FT 5.5 mm Anchor
` Spade Drill, 5.5 mm for use in hard bone with the
`FOOTPRINT PK 6.5 mm anchor and the TWINFIX FT 6.5 mm Anchor
`Disposable Tension Tuner
`
`Arthrex Exhibit 2003 - Page 14
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-14
`
`Rotator Cuff Soft Tissue Fixation – Non-absorbable Polymer Anchors
`KINSA™ RC Suture Anchor
`
`KINSA RC Suture Anchor
`The KINSA RC Suture Anchor, 5.5 mm combination tap-in and screw-in design, is for
`use in arthroscopic rotator cuff procedures. Made from radiolucent high strength
`non-absorbable PEEK-OPTIMA® polymer from Invibio®, the anchor is preloaded with
`ULTRABRAID™ COBRAID suture. A self-locking, sliding knot, based on the FAST-FIX™
`Meniscal Repair System technology, is contained within the anchor allowing secure
`fixation to occur without tying any knots. The design allows surgeons to insert the
`anchor then manually control exactly how much tension they wish to place across the
`rotator cuff tissue with tactile feedback. A suture loop surrounding the tissue is reduced,
`leaving a low profile repair with no knot stack on top of the cuff.
`
`Reference #
`72200895
`
`Instruments
`72201450
`72200867
`72200879
`
`Description
`KINSA RC Suture Anchor, sterile
`
`3.8 mm Straight Awl, disposable
`Mallet with nylon ends
`Replacement nylon end caps for mallet (set of 2)
`
`Arthrex Exhibit 2003 - Page 15
`
`Shoulder Arthroscopy
`
`

`
`Instability Soft Tissue Fixation
`BIORAPTOR™ CURVED and OSTEORAPTOR™ CURVED Suture Anchors and Guide System
`
`B-15
`
`The BIORAPTOR Curved and OSTEORAPTOR Curved Suture Anchors and Guide System are
`designed specifically to manage the surgical challenges of arthroscopic instability repair.
`
`Optimal Anchor Placement
` Curved drill guides with a 25º distal bend improve the trajectory of drilling and optimize
`anchor placement in the glenoid*
`
`Increased Access
`• Anchors can be placed confidently in the most inferior aspect of the glenoid without
`the need to compromise the subscapularis tendon†
` • The Curved Guide System removes the need to create additional working portals to
`access the repair site of a SLAP lesion†
`
`Suture Anchor Flexibility
`Achieve secure fixation from a choice of materials and sizes when using the BIORAPTOR 2.3
`mm PK or OSTEORAPTOR 2.3 mm PLLA-HA or OSTEORAPTOR 2.9 mm PLLA-HA, preloaded
`on flexible inserters with high-strength ULTRABRAID™ Suture
`
`Reference #
`72203280
`
`72203281
`
`72203290
`
`72203291
`
`72203424
`
`72203423
`
`Instruments
`72203156
`72203298
`72203459
`72203159
`72203460
`72203160
`72203372
`72203373
`72203484
`72203374
`72203485
`72203375
`
`Description
` 2.3 mm BIORAPTOR Curved PK Suture Anchor,
`with one ULTRABRAID (#2) Suture (COBRAID-black)
` 2.3 mm BIORAPTOR Curved PK Suture Anchor,
`with one ULTRABRAID (#2) Suture (COBRAID-blue)
` 2.3 mm OSTEORAPTOR Curved Suture Anchor,
`with one ULTRABRAID (#2) Suture (COBRAID-blue)
` 2.3 mm OSTEORAPTOR Curved Suture Anchor,
`with one ULTRABRAID (#2) Suture (COBRAID-black)
` 2.9 mm OSTEORAPTOR Curved Suture Anchor,
`with one ULTRABRAID (#2) Suture (blue)
` 2.9 mm OSTEORAPTOR Curved Suture Anchor,
`with two ULTRABRAID (#2) Sutures (blue, COBRAID-blue)
`
`Curved Drill Guide for 2.3 mm Curved Suture Anchors – Crown Tip
`Curved Drill Guide for 2.3 mm Curved Suture Anchors – Fishmouth Tip
`Curved Drill Guide for 2.3 mm Curved Suture Anchors – Reverse Fishmouth Tip
`Flexible Obturator for 2.3 mm Curved Suture Anchor System – Blunt
`Flexible Obturator for 2.3 mm Curved Suture Anchor System – Trocar Tip
`Flexible Drill for 2.3 mm Curved Suture Anchor System
`Curved Drill Guide for 2.9 mm Curved Suture Anchors – Crown Tip
`Curved Drill Guide for 2.9 mm Curved Suture Anchors – Fishmouth Tip
`Curved Drill Guide for 2.9 mm Curved Suture Anchors – Reverse Fishmouth Tip
`Flexible Obturator for 2.9 mm Curved Suture Anchor System – Blunt
`Flexible Obturator for 2.9 mm Curved Suture Anchor System – Trocar Tip
`Flexible Drill for 2.9 mm Curved Suture Anchor System
`
`Arthrex Exhibit 2003 - Page 16
`
`Crown Tip
`
`Fishmouth Tip
`
`* Data on file at Smith & Nephew, ITR-15001065, 2011
`† Data on file at Smith & Nephew, ITR-4616, 2011
`
`Call +1 800 343 5717 (U.S.) or contact your local representative.
`
`Shoulder Arthroscopy
`
`

`
`B-16
`
`Instability Soft Tissue Fixation – Non-absorbable Polymer Anchors
`BIORAPTOR™ 2.3 Suture Anchors
`
`BIORAPTOR 2.3 Suture Anchor
`The BIORAPTOR 2.3 PK Suture Anchor is a small diameter anchor for shoulder, hip and small
`joint repairs. Made with radiolucent high strength PEEK-OPTIMA® polymer from Invibio®,
`the anchor includes one pre-loaded ULTRABRAID™ suture. It also features the TWINFIX™ style
`handle inserter with depth stop. The instrumentation makes it easier to maneuver to any
`location inside the joint, so the repair can be positioned exactly where needed.
`
`Reference #
`72201541
`
`72201542
`
`72201543
`
`Instruments
`72201105
`72201106
`72201107
`72201108
`72201110
`72201111
`72201112
`7205395
`72200867
`72200879
`72201824
`
`Description
` 2.3 mm BIORAPTOR PK Suture Anchor with one
`ULTRABRAID #2 (COBRAID-blue) suture, sterile
` 2.3 mm BIORAPTOR PK Suture Anchor with one
`ULTRABRAID #2 (COBRAID-black) suture, sterile
` 2.3 mm BIORAPTOR PK Suture Anchor with one
`ULTRABRAID #2 (white) suture, sterile
`
`Inline Drill Guide – Fishmouth Tip
`Inline Obturator – Blunt Tip
`Inline Obturator – Cannulated
`Spade Drill Bit for 2.3 mm anchor
`Inline Drill Guide – Spike Tip
`Inline Drill Guide – Crown Tip
`Inline Obturator – Trocar Tip
`Guide Wire, Nitinol, 1.2 x 45L, non-sterile (3 per package)
`Mallet with nylon ends
`Replacement nylon end caps for mallet (set of 2)
`Twist tip drill bit for 2.3 mm BIORAPTOR Twist Drill for 2.3 mm anchor
`
`Arthrex Exhibit 2003 - Page 17
`
`Shoulder Arthroscopy
`
`

`
`Instability Soft Tissue Fixation – Suture Anchors
`BIORAPTOR™ Knotless Suture Anchors
`The BIORAPTOR Knotless Suture Anchor allows surgeons to control anchor tension in labral
`repairs post anchor insertion. Unlike other instability anchors, our knotless anchors do not
`rely on a bone-anchor interface for proper final fixation or suture security. Designed with an
`inner plug, the tension-ability and security of our sutures lies within the interior of the anchor.
`
`B-17
`
`Key Performance Characteristics
`Independent Suture Tensioning
`Our knotless anchor design gives surgeons the
`ability to tension the suture after anchor implantation.
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket