# K111272: Rhausler Plage Anterior Cervical Fusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Rhausler, Inc.
- Decided: Nov 29, 2011 after 209 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: 5 generations back to K010530 (2001). 12 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 1.
- K092521: ZUMA-C, Seaspine, Inc. (2010) Summary page 1.

## Most influential descendants
- K173128: Alamo® C (2018), 2 descendants of its own
- K251735: Stabilis SA Cervical Stand-Alone System (Various PNs) (2025), 1 descendant of its own
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own
- K252737: DeGen Medical Latitude-C AM Cervical Interbody Fusion System (2025), 0 descendants of its own
- K213115: CHENA-C Spacer System (2021), 0 descendants of its own

## Indications for use
Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

Source page: https://510kreport.com/device/K111272
Methodology: https://510kreport.com/methodology