# K121852: Synthes Zero-P Variable Angle (VA)

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine Co.Lp
- Decided: Jul 25, 2012 after 30 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). 51 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093762: Synthes Zero-P, Synthes Spine (2010) Summary page 1.
- K112459: Synthes Zero-P, Synthes Spine Co.Lp (2011) Summary page 1.
- K112068: Synthes Zero-P Variable Angle (VA), Synthes Spine Co.Lp (2011) Summary page 1.

## Most influential descendants
- K131429: Reliance Cervical Ibf System (2013), 24 descendants of its own
- K142269: Reliance Cervical IBF System (2015), 23 descendants of its own
- K172489: Reliance Cervical IBF System (2017), 16 descendants of its own
- K173102: Reliance Cervical IBF System (2017), 15 descendants of its own
- K212358: Romero Cervical Cage (2022), 6 descendants of its own

## Indications for use
The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. ODD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K121852
Methodology: https://510kreport.com/methodology