510(k) · Cleared

Cleared

Synthes Zero-P

K112459510(k) SpecialCleared Dec 12, 2011108-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes Spine Co.Lp · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Dec 12, 2011 as substantially equivalent to K072981 (Synthes Spine Co.Lp, 2008) and 2 other predicates after a 108-day review. Its family tree reaches back 12 generations to 2001. 277 later devices descend from it.

Decided: Dec 12, 2011
Review: 108 days
Class: Class II
Product code: OVE
Recalls: None
Predicates: 3

Its longest line of descent runs back 12 generations to K003155 (2001). 38 ancestors in all, the oldest K792352 (1979). 277 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
8 generations between
3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
1 generation backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
This deviceK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
Descendant · cites it directly · 235 of its ownK131449 Coalition SpacerGlobus Medical, Inc. · 2013
Descendant · 2 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
Descendant · 2 generations on · 152 of its ownK151939 COALITION SpacersGlobus Medical, Inc. · 2016
Descendant · 2 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
Descendant · 3 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016

Show all 12 generations

Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
11 generations backK012254 VBROsteotech, Inc. · 2001
10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
1 generation backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
This deviceK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011

Showing 5 of 277 descendants. See all descendants

Descendants cleared per year

2012high 46 (2023) · low 1 (2012)2026

Most influential descendants

Showing 5 of 277 · See all

K131449Coalition SpacerGlobus Medical, Inc. · 2013 · cites it directly235descendants
K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 2 generations on210descendants
K151939COALITION SpacersGlobus Medical, Inc. · 2016 · 2 generations on152descendants
K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 2 generations on149descendants
K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 3 generations on117descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−12	K003155	Vertebral Body Replacement	Osteotech, Inc.	2001	—
−11	K012254	VBR	Osteotech, Inc.	2001	—
−10	K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
−9	K023570	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
−8	K030601	Verte-Stack Spinal System	Medtronic Sofamor Danek	2003	—
−7	K040536	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2004	—
−6	K041556	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2004	—
−5	K043561	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2004	—
−4	K060719	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	2006	—
−3	K062133	Modification to Verte-Stack Spinal System	Medtronic Spinal and Biologics Div	2006	—
−2	K070173	Verte-Stack Spinal System	Medtronic Sofamor Danek, Inc.	2007	—
−1	K073285	Peek Prevail Cervical Interbody Device	Medtronic Sofamor Danek USA, Inc.	2008	—
0 (this device)	K112459	Synthes Zero-P	Synthes Spine Co.Lp	2011	—
+1	K131449	Coalition Spacer	Globus Medical, Inc.	2013	—
+2	K143578	SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…	Globus Medical, Inc.	2016	—
+2	K151939	COALITION Spacers	Globus Medical, Inc.	2016	—
+2	K152022	SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…	Globus Medical, Inc.	2017	—
+3	K161223	TransContinental® M Spacers and InterContinental® Plate-Spacers	Globus Medical, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1980	1	0
1984	1	0
1996	1	0
1998	1	0
2000	1	0
2001	4	0
2002	2	0
2003	2	0
2004	5	0
2005	1	0
2006	2	0
2007	2	0
2008	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2014	2	0
2015	2	0
2016	6	0
2017	11	0
2018	8	0
2019	10	0
2020	18	0
2021	24	0
2022	31	0
2023	46	0
2024	43	0
2025	44	0
2026	29	0

FIG. 1 — Lineage of K112459, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K072981	Synthes Zero-P Summary page 1 …Product Code OVE (Intervertebral Fusion Device w/ Integrated Fixation, Cervical) Predicate Devices: Synthes Zero-P System (K07298 1); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285). Devic…	Synthes Spine Co.Lp	2008	2
*	K093762	Synthes Zero-P Summary page 1 …ce w/ Integrated Fixation, Cervical) Predicate Devices: Synthes Zero-P System (K07298 1); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285). Device Description: The purpose of this submission is to introduce…	Synthes Spine	2010	1
*	K073285	Peek Prevail Cervical Interbody Device Summary page 1 …) Predicate Devices: Synthes Zero-P System (K07298 1); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285). Device Description: The purpose of this submission is to introduce an additional, larger footprint Zer…	Medtronic Sofamor Danek USA, Inc.	2008	—

Also cleared against K072981: 13 other devices →

What descends from it? (277)

See all 277

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131449	Coalition Spacer	Globus Medical, Inc.	2013	235
K141314	Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation	Spineart	2014	38
K121852	Synthes Zero-P Variable Angle (VA)	Synthes Spine Co.Lp	2012	30
K143214	SCARLET® AC-T Secured Anterior Cervical Cage	Spineart	2015	3
K192906	Mecta-C Stand Alone	Medacta International S.A.	2020	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 9 months on median.
3 of the 38 ancestors have a recall of any class.
Of its descendants, K131449 (Globus Medical, Inc., 2013) has gone furthest, with 235 descendants of its own.
13 other devices also cite its predicate K072981.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2007high 210 (2010) · low 56 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVE

2in 2021

2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2007high 250 (2013) · low 0 (2007)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-TlI. 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 as stated in the FDA summary.

https://510kreport.com/device/K112459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112459: Synthes Zero-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112459

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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