# K161280: Cervical Stand Alone System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Jun 17, 2016 after 42 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: 15 generations back to K003155 (2001). 90 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System, Orthofix, Inc. (2015) Summary page 4.

## Most influential descendants
- K211704: CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System (2021), 5 descendants of its own
- K172424: Velofix™ SA Cervical Cage (2017), 5 descendants of its own
- K213951: FORZA XP Expandable Spacer System (2022), 4 descendants of its own
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (2024), 2 descendants of its own
- K213791: Unispace SA Cervical Cage (2022), 2 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 and /or allograft comprised of cancellous and/or corticocancellous bone graft 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/K161280
Methodology: https://510kreport.com/methodology