# K132999: Cervical Stand Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Apr 14, 2014 after 202 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: 11 generations back to K841189 (1984). 57 ancestors in all.
281 later devices descend from it; 2 cite it directly.
0 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101812: Construx Mini Peek Spacer System, Orthofix, Inc. (2010) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 1.

## Most influential descendants
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System (2015), 280 descendants of its own
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices (2015), 202 descendants of its own
- K160924: Amendia Interbody Fusion Devices (2016), 166 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K150619: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System (2015), 107 descendants of its own

## Indications for use
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

Source page: https://510kreport.com/device/K132999
Methodology: https://510kreport.com/methodology