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Product Information

DIVERGENCE™ Anterior Cervical Fusion System Stand-Alone Interbody Cage

Plot a New CourseEverything we know about cervical technologies combined with the latest treatment philosophies has been engineered into the DIVERGENCE™ Stand-Alone Interbody Cage:

» All-in-one fusion device with internal screw fixation

» Reduced soft tissue retraction with laterally divergent bone screw technique

» Straight and angled awl, drill, drivers

» Guided and freehand technique

» Cortical cancellous screw technology designed to maximize bone purchase; featuring an enhanced driver interface

» Parallel and lordotic implants in multiple sizes

» Visual, tactile lock

DIVERGENCE™Anterior Cervical Fusion System Stand-Alone Interbody Cage

Guided insertion

All-in-one device with internal screw fixation

Laterally divergent screw technique

Dual thread screw/new interface

Multiple lordotic and parallel options

Find a New Angle on ExcellenceLaterally divergent, hyper-angulated screws can lessen surgical exposure and minimize retraction.

» 40° Cranial Caudal Angulation

Multiple bone screw insertion angles available for varying patient anatomy.

Freehand Inserter without Guide offers:

» 27° – 47° Cranial Caudal Angulation » 1.0° – 10.0° Lateral Divergent Angulation

Guided Inserter with Guide offers: » 8° Lateral Divergent Angulation

Laterally Divergent Trajectory

Convergent Trajectory

8°

40°

DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION5

DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION 6

Streamlined Surgical Technique

Disc/Interbody Prep

Device Placement Engage Lock

Trial

Awl Drill Screw Lock

Straight

Angled

Make Innovation Your DestinationWe are reinventing our anterior cervical fixation portfolio with your OR experience in mind.

» Straight and angled instruments for ease of technique

» Guided and freehand technique options

Gardening Osteophytes

Find a New User InterfaceThe DIVERGENCE™ Anterior Cervical Fusion System features a cortical-cancellous thread pattern, self-drilling and self-tapping options, and employs our proprietary hexalobe driver for an enhanced driver interface.

» Cortical thread designed to maximize interface with thin cortical shell

» 11mm, 13mm, & 15mm lengths » 3.5mm and 4.0mm bone screws » Self-drilling & Self-tapping » Variable only » Visual, tactile, rotational lock mechanism

Tune in for Positive FeedbackThe DIVERGENCE™ Anterior Cervical Fusion System lock utilizes the same driver used to seat the screws, and provides both visual and tactile feedback to indicate when it’s secure.

Cortical ThreadCancellous Thread

7 DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System

Numerous Size OptionsHeights:

» 5mm – 10mm (1mm increments)

» Anterior height (without teeth)

Footprints: » 15mm (w) x 12mm (d) » 17mm (w) x 14mm (d)

O° (Parallel) and 6° (Lordotic) Interbody Cage Options

Graft Volumes:

DIVERGENCE™ Stand Alone Interbody Cage Graft Volume Summary

15mm Wide × 12mm Deep Volume

17mm Wide × 14mm Deep Volume

Size Parallel Lordotic Parallel Lordotic5mm 0.35cc 0.31cc 0.57cc 0.50cc

6mm 0.41cc 0.37cc 0.66cc 0.59cc

7mm 0.46cc 043cc 0.75cc 0.68cc

8mm 0.52cc 0.48cc 0.85cc 0.78cc

9mm 0.58cc 0.54cc 0.94cc 0.87cc

10mm 0.66cc 0.60cc 1.04cc 0.97cc

15mm × 12mm 17mm × 14mm

5mm Height 10mm Height

DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION 8

DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION9

Set Ordering Information

Risks » Tissue or nerve damage caused by improper positioning and placement of implants or instruments » Fracture, microfracture, resorption, damage, or penetration of any spinal bone and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery

» Bending, and/or breakage of any or all of the components

SPS Number Description

SPS02658 SA GENERAL INSTRUMENT SET-LORDOTICSPS02666 SA PEEK LORDOTIC INTERBODY IMPLANTSSPS02668 SA SELF-DRILLING SCREWSSPS02729 DIVERGENCE™ SHIPPING KIT w/ 9mm Sterile Drill BitSPS02665 SA PEEK PARALLEL INTERBODY IMPLANTSSPS02659 SA PARALLEL TRIALSPS02669 SA SELF-TAPPING SCREWSSPS02664 5X12mm LORDOTIC & PARALLEL RASP SET

DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION 10

Indications

The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Notes

DIVERGENCE™ Anterior Cervical Plate System Stand-Alone Interbody Cage System | PRODUCT INFORMATION11

ZEVO™ Anterior Cervical Plate System | PRODUCT INFORMATION 12

The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgment of the surgeon exercised before and during surgery as to the best mode of treatment for each patient.

Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.

Medtronic Sofamor Danek USA, Inc. 1800 Pyramid PlaceMemphis, TN 38132

(901) 396-3133(800) 876-3133Customer Service: (800) 933-2635

Medtronic Spinal and Biologics Business Worldwide Headquarters

2600 Sofamor Danek DriveMemphis, TN 38132

www.medtronic.com

Consult instructions for use at this website www.medtronic.com/manuals.

Note: Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.

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