# K112444: Anatomic Peek Cervical Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danck USA, Inc.
- Decided: Nov 15, 2011 after 83 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 13 generations back to K003155 (2001). 88 ancestors in all.
324 later devices descend from it; 5 cite it directly.
1 of 413 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070173: Verte-Stack Spinal System, Medtronic Sofamor Danek, Inc. (2007) Summary page 2.
- K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 2.
- K094042: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek (2010) Summary page 2.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 2.
- K093093: Small Plateau Spacer System, Life Spine (2010) Summary page 2.

## Most influential descendants
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst (2013), 281 descendants of its own
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 descendants of its own
- K161379: ELSA Spacers (2016), 155 descendants of its own
- K142559: ELEVATE Spinal System (2015), 130 descendants of its own

## Indications for use
The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for 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. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC® PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K112444
Methodology: https://510kreport.com/methodology