# K112388: Lanx Cervical SA

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Dec 16, 2011 after 120 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: 13 generations back to K003155 (2001). 33 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K094042: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek (2010) Summary page 1.

## Most influential descendants
- K132894: Optio-C Anterior Cervical System (2014), 24 descendants of its own
- K173077: Cavetto-SA Cervical Cage System (2018), 21 descendants of its own
- K200115: Cavetto-SA Cervical Cage System (2020), 19 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K223105: Tesera-K SC System (2022), 5 descendants of its own

## Indications for use
The Lanx Cervical SA System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine (C3-T 1) at one level. DDD is defined as discogenic pain with deg~eneration of the disc confirmed by history and radiographic studics. Thobse Patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Lanx Cervical SA is to be tilled with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

Source page: https://510kreport.com/device/K112388
Methodology: https://510kreport.com/methodology