# K112068: Synthes Zero-P Variable Angle (VA)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Nov 7, 2011 after 110 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K003155 (2001). 48 ancestors in all.
33 later devices descend from it; 3 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)
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K050451: Synthes Vectra System, Synthes Spine Co.Lp (2005) Summary page 1.
- K051665: Synthes Vectra-T System, Synthes Spine (2005)
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K073285: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.
- K092070: Interplate C, Rsb Spine, LLC (2009) Summary page 1.

## Most influential descendants
- K121852: Synthes Zero-P Variable Angle (VA) (2012), 30 descendants of its own
- 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

## Recalls of this device
- Sep 30, 2013 · Class II · Z-0455-2014: A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.

## 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-TI. DDD 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/K112068
Methodology: https://510kreport.com/methodology