# K121136: Renoir Posterior Cervial Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Accel Spine
- Decided: Aug 9, 2012 after 118 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K853033 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System, Spinal Concepts, Inc. (2003) Summary page 1.
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 1.
- K060152: Modification to S4 Spinal System, Aesculap, Inc. (2006) Summary page 1.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K103414: Venus Cervical Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 1.
- K120879: Lexus Cervical Fixation System, L&K BIOMED Co., Ltd. (2012). Cleared while this submission was under review Summary page 1.

## Indications for use
The RENOIR Posterior Cervical Fixation System is indicated for the following: * DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal stenosis * Fracture/dislocation * Failed previous fusion * Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (ClI -T3) spine. The pedicle screws are limited to placement in TI -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

Source page: https://510kreport.com/device/K121136
Methodology: https://510kreport.com/methodology