# K073285: Peek Prevail Cervical Interbody Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 15, 2008 after 174 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003155 (2001). 29 ancestors in all.
637 later devices descend from it; 14 cite it directly.
1 of 667 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 2.
- K070173: Verte-Stack Spinal System, Medtronic Sofamor Danek, Inc. (2007) Summary page 2.
- K062073: Verte-Stack Spinal System, Medtronic Sofamor Danek (2006) Summary page 2.
- K061274: Venture Anterior Cervical Plate System, Medtronic Sofamor Danek (2006) Summary page 2.

## Cited in the summary but kept off the family tree
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K094042: Peek Prevail Cervical Interbody Device (2010), 397 descendants of its own
- K100214: Cornerstone PSR Cervical Interbody Fusion Device (2010), 389 descendants of its own
- K111264: Cornerstone (R) PSR Cervical Fusion System (2011), 331 descendants of its own
- K133494: Chesapeake Spinal System (2014), 330 descendants of its own
- K112444: Anatomic Peek Cervical Fusion System (2011), 324 descendants of its own

## Indications for use
The PEEK PREVAIL™ Cervical Interbody Device is indicated for 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 PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws, The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K073285
Methodology: https://510kreport.com/methodology