# K072981: Synthes Zero-P

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Feb 11, 2008 after 111 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010530 (2001). 7 ancestors in all.
546 later devices descend from it; 14 cite it directly.
0 of 554 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K011037: Vertebral Spacer, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K100698: STCC (2011), 346 descendants of its own
- K111439: Chesapeake (Cervical Components) (2011), 345 descendants of its own
- K133494: Chesapeake Spinal System (2014), 330 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K093762: Synthes Zero-P (2010), 306 descendants of its own

## Recalls of this device
- Sep 23, 2011 · Not classified · Z-0104-2012: LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a
- Feb 10, 2009 · Not classified · Z-1348-2009: Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.

## Indications for use
The Synthes Zero-P 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. 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 should be packed with autogenous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K072981
Methodology: https://510kreport.com/methodology