# K093762: Synthes Zero-P

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine
- Decided: Dec 20, 2010 after 378 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: 4 generations back to K010530 (2001). 8 ancestors in all.
306 later devices descend from it; 3 cite it directly.
0 of 315 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.

## Most influential descendants
- K112459: Synthes Zero-P (2011), 277 descendants of its own
- K131449: Coalition Spacer (2013), 235 descendants of its own
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K151939: COALITION Spacers (2016), 152 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 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

## 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-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 should be packed with autogenous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K093762
Methodology: https://510kreport.com/methodology