# K152193: Renovis Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, Inc.
- Decided: Sep 25, 2015 after 51 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K973854 (1998). 17 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 5.
- K102820: Appliance, Fixation, Spinal Intervertebral Body, Alphatec Spine, Inc. (2010) Summary page 5.

## Most influential descendants
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Indications for use
The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions: * degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * trauma (i.e., fracture or dislocation) * spinal stenosis * tumor * pseudoarthrosis * failed previous fusion WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K152193
Methodology: https://510kreport.com/methodology