# K152793: Unison-C Anterior Cervical Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
- Decided: Jan 19, 2016 after 113 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: 14 generations back to K841189 (1984). 144 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121151: Pro-Link Cervical Spacer System, Life Spine, Inc. (2012) Summary page 5.
- K142079: Stalif Cti, Stalif C, Centinel Spine, Inc. (2014) Summary page 5.
- K113796: Solitaire-C Cervical Spacer System, Ebi, LLC (2012) Summary page 5.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 5.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 5.
- K142218: Coalition AGX Plate and Coalition AGX Spacer, Globus Medical, Inc. (2015) Summary page 5.

## Most influential descendants
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 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
- K223190: Hive™ Standalone Cervical System (2022), 5 descendants of its own
- K170830: Unison-C Anterior Cervical Fixation System (2017), 5 descendants of its own

## Indications for use
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K152793
Methodology: https://510kreport.com/methodology