throbber
APPLICATION SPECIFIC SOLUTIONS
`NuVasive® is the first company to provide a full portfolio of interbody
`solutions with a variety of applications via the CoRoent® XL platform.
`
`XL (18mm wide)
`
`XL-W (22mm wide)
`
`XL-XW (26mm wide)
`
`XL-F (18mm wide)
`
`XL-F Wide (22mm wide)
`
`Implants offered in 0° and 10° lordosis.
`
`Max. Stability,
`Advanced
`
`XL-CT (Coronal Tapered)
`
`XL-K (Keeled)
`
`XL-T (Thoracic)
`
`X-CORE 2 Expandable VBR
`Tumor/Trauma Corpectomy*
`
`XL-H (Hyderlordotic)
`Anterior Column Realignment*
`
`More
`Complex
`
`Note: FDA PEEK Implant Clearances:
`All PEEK interbody implants are cleared for use as intervertebral body fusion devices at L2-S1 for use with autograft, and supplemental fixation, including the CoRoent
`family of implants.
`
`24
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`STEP 10:
`IMPLANT PLACEMENT
`The appropriate implant from the CoRoent® XL
`portfolio is selected and filled with graft material.
`Refer to the CoRoent XL brochure for detailed
`implant selection information.
`
`A loading block can be used to ensure that the
`CoRoent XL graft windows are completely filled.
`(Fig. 62)
`
`(Fig. 62)
`
`25
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`STEP 10:
`IMPLANT PLACEMENT (CONT’D)
`XLIF Slides may be used to protect the endplates
`and contain graft material during implant insertion.
`Fluoroscopy should be used to verify XLIF Slides
`are positioned properly. The Inserter is placed with
`the attached implant between the XLIF Slides. The
`implant is advanced across the disc space under AP
`fluoroscopy.
`
`During insertion of the implant, placement is also
`monitored with NVM5® Free Run EMG. Placement of
`the implant is dictated by patient anatomy and the
`spinal pathology that is being treated. Generally, the
`implant spans the ring apophysis, is centered across
`the disc space from a medial/lateral perspective, and
`is near the center of the disc space from an anterior/
`posterior perspective (Figs. 63, 64).
`
`All CoRoent® XL implants have titanium markers that
`can be used confirm correct implant alignment
`(Figs. 65, 66, 67).
`
`(Fig. 63)
`
`(Fig. 64)
`
`26
`
`(Fig. 65)
`
`(Fig. 66)
`
`(Fig. 67)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`STEP 10:
`IMPLANT PLACEMENT (CONT’D)
`Coroent® XL Implants may also be inserted with the
`TL Graft Containment Slide. The implant is attached
`to the Inserter, and the TL Graft Containment
`Slide is snapped onto the inserter. The implant is
`gently impacted into the disc space as the TL Graft
`Containment Slide keeps graft material inside the
`implant (Fig. 68).
`
`(Fig. 68)
`
`27
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`STEP 11:
`XLP® PLATE
`The XLP plate is one of many supplemental fixation
`options available for XLIF. A brief overview of the XLP
`plate surgical technique is described below. Proper
`patient selection and technique is critical to ensure
`success with lateral plating. For additional details on
`the XLP plate or other fixation options, please refer to
`the appropriate product technique guide.
`
`Pilot hole preparation and bolt insertion are
`performed through XLP Guides. The appropriately
`sized Guide is introduced through the XLIF exposure
`and centered over the disc space. With the Guide
`properly positioned, the spikes are inserted into both
`vertebral bodies to secure them into place (Fig. 69).
`
`Several instruments are available in the XLP set to
`create pilot holes including taps, drills, and awls. The
`selected instrument(s) should be inserted through
`the XLP Guide and a pilot hole created to the desired
`depth and trajectory (Fig. 70).
`
`28
`
`(Fig. 69)
`
`(Fig. 70)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`STEP 11:
`XLP® PLATE (CONT’D)
`With a pilot hole prepared, the appropriate length bolt
`is introduced through the Guide barrel and inserted
`to appropriate depth (Fig. 71). Bolt insertion is
`repeated on the adjacent level. Bicortical bolts, placed
`as parallel as possible, are recommended.
`
`With both bolts in place, the appropriately sized
`plate is inserted over both bolts, ensuring the heads
`are properly exposed above the Plate for Lock Nut
`insertion. After verification that the Plate is fully
`seated, Lock Nuts are inserted onto both bolts.
`
`Prior to final tightening of Lock Nuts, the table should
`be flattened (i.e., table break removed).
`
`Final tightening on both Lock Nuts (Fig. 72)
`completes the procedure (Fig. 73).
`
`(Fig. 72)
`
`(Fig. 71)
`
`(Fig. 72)
`
`(Fig. 73)
`
`29
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`MAXIMUMACCESS SURGICAL PLATFDRM
`
`XL|F® SURGICAL TECHNIQUE
`
`XLIF® APPLICATIONS
`XLIF“'¥‘7 APPLICATIONS
`
`DEGENERATIVE DISC DISEASE
`DEGENERATIVE DISC DISEASE
`
`PRE-OP
`PRE-OP
`
`POST-OP
`POST-OP
`
`
`
`DEGENERATIVE SPONDYLOLISTHESIS SECONDARY TO ADVANCED DDD
`DEGENERATIVE SPONDYLOLISTHESIS SECONDARY TO ADVANCED DDD
`PRE-OP
`POST-OP
`PRE-OP
`POST-OP
`
`
`
`30
`30
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`XL|F® SURGICAL TECHNIQUE
`
`XLIF® APPLICATIONS (CONT’D)
`XLlF"9‘7 APPLICATIONS (CONT'D)
`
`DEGENERATIVE SCOLIOSIS SECONDARY TO ADVANCED DDD
`DEGENERATIVE SCOLIOSIS SECONDARY TO ADVANCED DDD
`PRE-OP
`POST-OP
`PRE-OP
`POST-OP
`
`
`
`ADJACENT SEGMENT DISEASE SECONDARY TO ADVANCED DDD
`ADJACENT SEGMENT DISEASE SECONDARY TO ADVANCED DDD
`PRE-OP
`POST-OP
`PRE-OP
`POST-OP
`
`
`
`31
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`(Fig. 74)
`
`STEP 12:
`REMOVAL AND CLOSURE
`Once the procedure is completed, the Access Driver
`is removed while using direct visualization to verify
`the absence of significant bleeding in the disc space
`or psoas muscle. The Locking Intradiscal Shim should
`be removed from the C Blade prior to removing the
`Access Driver.
`
`The skin is closed using standard surgical techniques.
`
`Supplemental instrumentation is required
`and warranted.
`
`STEP 13:
`IMPLANT REMOVAL
`If it becomes necessary to revise the implanted
`CoRoent device, access to the implantation site can
`be achieved in a similar fashion to the original access.
`Once the implanted device is exposed, it can be
`removed by reattaching the Inserter. If the device
`is difficult to remove, additional engagement or
`dislodging may be achieved with the XLIF Revision
`Instruments.
`
`All supplemental instrumentation should be
`revised in accordance with its respective product
`technique guide.
`
`32
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`
`MAXCESS® 4 ACCESS SYSTEM
`
`Access Driver Body
`
`Solid Access Driver Body
`
`4th Blade Attachment
`
`Access Driver Handle Left
`
`Access Driver Handle Right
`
`Blades - 90, 100, 110, 120, 130, 140 150mm
`
`Wide Anterior Retractor, Short
`
`Blade Rotation Driver
`
`33
`
`XLIF ® SYSTEM
`
`

`
`MAXCESS® 4 ACCESS SYSTEM (CONT’D)
`
`Targeting Instrument
`
`MaXcess 4 Sterilization Case
`
`Lock Shim Inserter / Repositioning Tool
`
`Lock Shim Removal Tool
`
`MaXcess 4 Sterilization Case, Top Tray
`
`Anterior Crossbar
`
`Electrode Removal Tool
`
`MaXcess 4 Sterilization Case, Middle Tray
`
`Blades - 50, 60, 70, 80mm
`
`MaXcess 4 Sterilization Case, Bottom Tray
`
`34
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SYSTEM
`
`

`
`MAXCESS® 4 DISPOSABLES
`
`MaXcess 4 Kit
`
`MaXcess 4 Shim Kit
`
`MAXCESS 4 ARTICULATING ARM
`
`MaXcess 4 Articulating Arm
`
`MaXcess 4 Articulating Arm Sterilization Case
`
`MaXcess 4 Articulating Arm Bedrail Clamp
`
`MaXcess 4 Articulating Arm Sterilization Case Base
`
`35
`
`XLIF ® SYSTEM
`
`

`
`XLIF® INSTRUMENTS
`
`Broaches - 6, 8, 10, 12, 14mm x 18mm
`
`Paddle Shaver - 8, 10, 12, 14, 16mm
`
`Paddle Sizers - 8, 10, 12, 14, 16mm
`
`Psoas Retractors - 4, 10mm
`
`XLIF Distractor
`
`Distraction Tangs - 40, 50, 60mm
`
`Implant Tamp
`
`XLIF Slides
`
`Envoy XLIF T-Handle
`
`EnVoy™ XLIF Delivery System Body
`
`EnVoy XLIF Hex Driver
`
`Hudson T-Handle
`
`36
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SYSTEM
`
`

`
`ANTERIOR/LATERAL GENERAL INSTRUMENTS (TRAY ONE)
`
`Kerrison Rongeurs - 3, 5mm
`
`Pituitary Rongeurs - Medium, Large
`
`Bipolar Forceps - Angled, Straight
`
`Bipolar Forceps Cable
`
`Chisels - 7, 12mm Straight
`
`Nerve Retractor
`
`Suction Nerve Retractor
`
`Penfield - Push, Pull Long
`
`Suction - 10 FR, 12 FR Long
`
`Implant Removal Tool
`
`Threaded Hudson Adapter
`
`Slap Hammer
`
`37
`
`XLIF ® SYSTEM
`
`

`
`ANTERIOR/LATERAL GENERAL INSTRUMENTS (TRAY TWO)
`
`Curettes - Straight, Up, Down; Small, Medium, Large
`
`Serrated Rasp
`
`Endplate Scraper - Push, Pull
`
`Disc Cutter - 8, 10, 12, 14mm
`
`Cobb Elevator - Straight, Down; Small, Large
`
`NVM5® SYSTEM
`
`Control Unit
`
`Patient Module
`
`NVM5 Disposable Dilator Kit
`
`EMG Harness
`
`Reference, Anode, And Recording Needle Electrodes (Sterile)
`
`Reference, Anode, And Recording Surface Electrodes
`
`38
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SYSTEM
`
`

`
`MAXCESS® 4 XLIF®
`
`SYSTEMS
`
`MaXcess 4 Access System
`MaXcess 4 Articulating Arm
`MaXcess 4 Kit
`XLIF Instruments
`Anterior/Lateral General Instruments (Tray One)
`Anterior/Lateral General Instruments (Tray Two)
`NVM5 System
`NVM5 Disposables
`
`MAXCESS 4 ACCESS SYSTEM
`
`DESCRIPTION
`
`Dilator - 6mm
`
`Dilator - 9mm
`
`Dilator - 12mm
`
`Hex Driver (3/32”)
`
`Hex Key (3/32”)
`
`Light Cable Adapter, ACMI
`
`Light Cable Adapter, Storz
`
`Light Cable Adapter, Olympus
`
`Fixation Shim Screw Driver
`
`Bayonetted Shim Inserter
`
`Fluoro Modulator
`
`K-Wire (13.5”)
`
`Initial Dilator Holder
`
`Targeting Instrument
`
`Lock Shim Inserter/ Repositioning Tool
`
`Lock Shim Removal Tool
`
`Anterior Crossbar
`
`MaXcess 4 4th Blade Attachment
`
`Blade Rotation Driver
`
`MAXCESS 4 DISPOSABLES
`
`DESCRIPTION
`
`MaXcess 4 Kit
`MaXcess 4 Shim Kit
`Light Cable (Sterile)
`Annulotomy Knife
`K-Wire (13.5”)
`MaXcess Fixation Shim Kit
`
`CATALOG #
`
`3240060
`3240061
`3200220
`3101055
`3230101
`3200028
`
`CATALOG #
`
`DESCRIPTION
`
`CATALOG #
`
`1010966
`
`1010967
`
`1010968
`
`1011691
`
`1011748
`
`1011810
`
`1011811
`
`1011812
`
`3200052
`
`3200215
`
`3220131
`
`3230101
`
`3230140
`
`3240000
`
`3240001
`
`3240002
`
`3240003
`
`3240004
`
`3240005
`
`Electrode Removal Tool
`
`Shim Tamp/Retrieval Tool
`
`MaXcess 4 Set Screw, Short
`
`MaXcess IV Caddy, Sterilization Case
`
`Wide Anterior Retractor, Short
`
`Wide Anterior Retractor, Long
`
`Narrow Anterior Retractor, Short
`
`Narrow Anterior Retractor, Long
`
`MaXcess 4 Set Screw, Long
`
`MaXcess 4 Set Screw, Knurled
`
`MaXcess 4 Access Driver Body
`
`MaXcess 4 Solid Access Driver Body
`
`Access Driver Handle, Left
`
`Access Driver Handle, Right
`
`MaXcess 4 Sterilization Case, Base
`
`Generic NuVasive® Tray Lid
`
`MaXcess 4 Sterilization Case, Top Tray
`
`MaXcess 4 Sterilization Case, Middle Tray
`
`MaXcess 4 Sterilization Case, Bottom Tray
`
`3240006
`
`3240007
`
`3240008
`
`3240026
`
`3240028
`
`3240029
`
`3240030
`
`3240031
`
`3240032
`
`3240033
`
`3240309
`
`3240310
`
`3240312
`
`3240311
`
`3240020
`
`8801333
`
`3240022
`
`3240023
`
`3240024
`
`39
`
`CATALOG
`
`

`
`MAXCESS® 4 ACCESS SYSTEM (CONT’D)
`
`DESCRIPTION
`
`50mm Left Blade
`
`60mm Left Blade
`
`70mm Left Blade
`
`80mm Left Blade
`
`90mm Left Blade
`
`100mm Left Blade
`
`110mm Left Blade
`
`120mm Left Blade
`
`130mm Left Blade
`
`140mm Left Blade
`
`150mm Left Blade
`
`160mm Left Blade
`
`50mm Right Blade
`
`60mm Right Blade
`
`70mm Right Blade
`
`80mm Right Blade
`
`90mm Right Blade
`
`100mm Right Blade
`
`110mm Right Blade
`
`120mm Right Blade
`
`130mm Right Blade
`
`140mm Right Blade
`
`CATALOG #
`
`DESCRIPTION
`
`CATALOG #
`
`150mm Right Blade
`160mm Right Blade
`90mm Electrode Center Blade
`100mm Electrode Center Blade
`110mm Electrode Center Blade
`120mm Electrode Center Blade
`130mm Electrode Center Blade
`140mm Electrode Center Blade
`150mm Electrode Center Blade
`160mm Electrode Center Blade
`50mm Aluminum Center Blade
`60mm Aluminum Center Blade
`70mm Aluminum Center Blade
`80mm Aluminum Center Blade
`90mm Aluminum Center Blade
`100mm Aluminum Center Blade
`110mm Aluminum Center Blade
`120mm Aluminum Center Blade
`130mm Aluminum Center Blade
`140mm Aluminum Center Blade
`150mm Aluminum Center Blade
`160mm Aluminum Center Blade
`
`3242150
`3242160
`3243090
`3243100
`3243110
`3243120
`3243130
`3243140
`3243150
`3243160
`3244050
`3244060
`3244070
`3244080
`3244090
`3244100
`3244110
`3244120
`3244130
`3244140
`3244150
`3244160
`
`3241050
`
`3241060
`
`3241070
`
`3241080
`
`3241090
`
`3241100
`
`3241110
`
`3241120
`
`3241130
`
`3241140
`
`3241150
`
`3241160
`
`3242050
`
`3242060
`
`3242070
`
`3242080
`
`3242090
`
`3242100
`
`3242110
`
`3242120
`
`3242130
`
`3242140
`
`MAXCESS 4 ARTICULATING ARM
`
`DESCRIPTION
`
`MaXcess 4 Articulating Arm
`
`MaXcess 4 Articulating Arm Bedrail Clamp
`
`MaXcess 4 Articulating Arm Sterilization Case Base
`
`Generic NuVasive® Tray Lid
`
`CATALOG #
`
`3240121
`
`3240122
`
`3240025
`
`8801333
`
`40
`
`CATALOG
`
`

`
`XLIF® INSTRUMENTS
`
`ANTERIOR/LATERAL GENERAL INSTRUMENTS (TRAY ONE)
`
`DESCRIPTION
`
`Hudson T-Handle
`
`Implant Tamp
`
`Psoas Retractor - 4mm
`
`Psoas Retractor - 10mm
`
`Distractor
`
`Paddle Sizer - 8mm
`
`Paddle Sizer - 10mm
`
`Paddle Sizer - 12mm
`
`Paddle Sizer - 14mm
`
`Paddle Sizer - 16mm
`
`Paddle Shaver - 8mm
`
`Paddle Shaver - 10mm
`
`Paddle Shaver - 12mm
`
`Paddle Shaver - 14mm
`
`Paddle Shaver - 16mm
`
`Broach - 6 x 18mm
`
`Broach - 8 x 18mm
`
`Broach - 10 x 18mm
`
`Broach - 12 x 18mm
`
`Broach - 14 x 18mm
`
`Instruments Sterilization Case
`
`XLIF Slides
`XLIF Slides 40mm EnVoy™ XLIF Distraction Tangs
`50mm EnVoy XLIF Distraction Tangs
`
`60mm EnVoy XLIF Distraction Tangs
`
`EnVoy XLIF Delivery System
`
`EnVoy XLIF Hex Driver
`
`EnVoy XLIF T-Handle
`
`CATALOG #
`
`DESCRIPTION
`
`CATALOG #
`
`Bipolar Forceps Cable
`
`Nerve Retractor - Long
`
`Suction Nerve Retractor - Long
`
`Suction - 10 FR Long
`
`Suction - 12 FR Long
`
`Bipolar Forceps - Angled
`
`Bipolar Forceps - Straight
`
`Penfield - Long, Push
`
`Penfield - Long, Pull
`
`Slap Hammer
`
`Threaded Hudson Adapter
`
`Implant Removal Tool
`
`7mm Chisel - Straight
`
`12mm Chisel - Straight
`
`Kerrison Rongeur - 3mm
`
`Kerrison Rongeur - 5mm
`
`Pituitary Rongeur - Medium
`
`Pituitary Rongeur - Large
`
`ALGI Sterilization Case One
`
`3100052
`
`3300014
`
`3300015
`
`3300017
`
`3300028
`
`3300012
`
`3300022
`
`3300118
`
`3300218
`
`5000120
`
`5001901
`
`6600171
`
`6900123
`
`6900124
`
`6900133
`
`6900135
`
`6900430
`
`6900431
`
`6900089
`
`1001992
`
`3300020
`
`3300023
`
`3300024
`
`3300040
`
`3300608
`
`3300610
`
`3300612
`
`3300614
`
`3300616
`
`3300808
`
`3300810
`
`3300812
`
`3300814
`
`3300816
`
`5001206
`
`5001208
`
`5001210
`
`5001212
`
`5001214
`
`3300130
`
`3300063
`
`3300051
`
`3300052
`
`3300053
`
`3300055
`
`3300056
`
`3300058
`
`41
`
`CATALOG
`
`

`
`ANTERIOR/LATERAL GENERAL INSTRUMENTS (TRAY TWO)
`
`NVM5® SYSTEM
`
`DESCRIPTION
`
`8mm Disc Cutter
`10mm Disc Cutter
`12mm Disc Cutter
`14mm Disc Cutter
`Cobb Elevator - Straight, Large
`Cobb Elevator - Straight, Small
`Cobb Elevator - Down, Large
`Cobb Elevator - Down, Small
`Straight Curette - Large
`Straight Curette - Medium
`Straight Curette - Small
`Up-Angled Curette - Large
`Up-Angled Curette - Medium
`Up-Angled Curette - Small
`Down-Facing Curette - Large
`Down-Facing Curette - Medium
`Down-Facing Curette - Small
`Endplate Scraper - Push, Large
`Endplate Scraper - Pull, Large
`Serrated Rasp
`ALGI Sterilization Case Two
`
`CATALOG #
`
`DESCRIPTION
`
`6900151
`6900152
`6900153
`6900154
`6900220
`6900222
`6900221
`6900223
`6900300
`6900310
`6900301
`6900306
`6900305
`6900314
`6900309
`6900308
`6900307
`6900320
`6900321
`6900340
`6900095
`
`NVM5 System Includes:
` NVM5
` Control Unit
` Patient Module
` Keyboard
` (2) Connection Cables
` Impedance Meter
` Impedance Meter Leads
` NVM5 Product Reference Manual
`
`NVM5 DISPOSABLES
`
`DESCRIPTION
`
`NVM5 XLIF® Module Kit Options:
`Surface Electrodes
` NVM5 Surface Module
` (1) NVM5 Probe (Sterile)
` (1) NVM5 Probe (Sterile)
` (1) NVM5 Clip
` XLIF Disposable Dilators
` (2) K-Wires
`Needle Electrodes
` NVM5 Needle Module
` NVM5 Needle Module
` (1) NVM5 Probe (Sterile)
` (1) NVM5 Clip
` XLIF Disposable Dilators
` (2) K-Wires
`
`CATALOG #
`
`NVM5
`
`CATALOG #
`
`8020029
`
`8050029
`
`42
`
`CATALOG
`
`

`
`
`
`43
`
`

`
`EC
`
`REP
`
`To order, please contact your NuVasive® Sales Consultant or Customer Service Representative today at:
`NuVasive, Inc. 7475 Lusk Blvd., San Diego, CA 92121 • phone: 800-475-9131 fax: 800-475-9134
`NuVasive UK Ltd. Suite B, Ground Floor, Caspian House, The Waterfront, Elstree, Herts WD6 3BS UK
`phone: +44 (0) 208-238-7850 fax: +44 (0) 207-998-7818
`www.nuvasive.com
`, NuVasive, Speed of Innovation, Armada, CoRoent, DBR, MAS, MaXcess, NVM5, Radian, SpheRx, X-CORE, XLIF,
`©2013. NuVasive, Inc. All rights reserved.
`and XLP are registered trademarks of NuVasive, Inc. EnVoy and Precept are common law trademarks of NuVasive, Inc.
`
`9500138 E
`
`0086

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