510(k) · Cleared
Recalled · 2011Synthes Zero-P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 20, 2010 as substantially equivalent to K072981 (Synthes Spine Co.Lp, 2008) after a 378-day review. Its family tree reaches back 4 generations to 2001. 306 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2010
- Review
- 378 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010530 (2001). 8 ancestors in all, the oldest P950002 (1996). 306 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 3 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 2 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 1 generation backK072981 Synthes Zero-PSynthes Spine Co.Lp · 2008 · Recalled
- This deviceK093762 Synthes Zero-PSynthes Spine · 2010
- Descendant · cites it directly · 277 of its ownK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- Descendant · 2 generations on · 235 of its ownK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · 3 generations on · 152 of its ownK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- Descendant · 3 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
Showing 5 of 306 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 306 · See all- K112459Synthes Zero-PSynthes Spine Co.Lp · 2011 · cites it directly277descendants
- K131449Coalition SpacerGlobus Medical, Inc. · 2013 · 2 generations on235descendants
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 3 generations on210descendants
- K151939COALITION SpacersGlobus Medical, Inc. · 2016 · 3 generations on152descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 3 generations on149descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −3 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −2 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −1 | K072981 | Synthes Zero-P | Synthes Spine Co.Lp | 2008 | 2 |
| 0 (this device) | K093762 | Synthes Zero-P | Synthes Spine | 2010 | — |
| +1 | K112459 | Synthes Zero-P | Synthes Spine Co.Lp | 2011 | — |
| +2 | K131449 | Coalition Spacer | Globus Medical, Inc. | 2013 | — |
| +3 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +3 | K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 | — |
| +3 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 12 | 0 |
| 2018 | 8 | 0 |
| 2019 | 11 | 0 |
| 2020 | 21 | 0 |
| 2021 | 27 | 0 |
| 2022 | 35 | 0 |
| 2023 | 49 | 0 |
| 2024 | 46 | 0 |
| 2025 | 44 | 0 |
| 2026 | 34 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072981 | Synthes Zero-PSummary page 1…rols) Orthopaedic and Rehabilitation Devices Panel Product Code: ODP Predicate Device: Synthes Zero-P System is substantially equivalent to the Synthes Zero-P System (K072981). Device Description: The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P… | 2008 |
What descends from it? (306)
See all 3063 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2011 | Not classified | Z-0104-2012 | Labeling False and Misleading | 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 cervical interbody spacer. PEEK-CR is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K112459 (Synthes Spine Co.Lp, 2011) has gone furthest, with 277 descendants of its own.
- 13 other devices also cite its predicate K072981.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093762 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093762: Synthes Zero-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093762
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026