# K111264: Cornerstone (R) PSR Cervical Fusion System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA
- Decided: Oct 12, 2011 after 161 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). 87 ancestors in all.
331 later devices descend from it; 6 cite it directly.
1 of 419 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 2.
- K041197: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K093093: Small Plateau Spacer System, Life Spine (2010) Summary page 2.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) 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 CORNERSTONE® PSR Cervical device 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 CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

Source page: https://510kreport.com/device/K111264
Methodology: https://510kreport.com/methodology