`
`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.
`