510(k) Report

510(k) · Cleared

Recalled · 2011

Synthes Zero-P

K072981510(k) TraditionalCleared Feb 11, 2008111-day reviewClass II21 CFR 888.3080Recalls 2

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 Feb 11, 2008 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 3 other predicates after a 111-day review. Its family tree reaches back 3 generations to 2001. 546 later devices descend from it. It has been recalled 2 times.

Decided
Feb 11, 2008
Review
111 days
Class
Class II
Product code
OVE
Recalls
2
Predicates
4

Its longest line of descent runs back 3 generations to K010530 (2001). 7 ancestors in all, the oldest P950002 (1996). 546 later devices descend from it, 14 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2001: 1 other ancestor1996: 1 other ancestor2010: 3 descendants cleared2011: 8 descendants cleared2016: 17 descendants cleared2015: 13 descendants cleared2012: 3 descendants cleared2017: 32 descendants cleared2026: 54 descendants cleared2023: 70 descendants cleared2019: 34 descendants cleared2014: 5 descendants cleared2013: 3 descendants cleared2020: 50 descendants cleared2021: 48 descendants cleared2018: 29 descendants cleared2025: 61 descendants cleared2022: 56 descendants cleared2024: 60 descendants clearedK010530 · Geo Structure · Interpore Cross Intl. · 2001K062083 · Synfix -LR · Synthes Spine Co.Lp · 2007K072253 · Synfix-LR Spacer · Synthes Spine Co.Lp · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 14 descendants2 generations forward: 46 descendants3 generations forward: 87 descendants4 generations forward: 97 descendants5 generations forward: 114 descendants6 generations forward: 90 descendants7 generations forward: 48 descendants8 generations forward: 23 descendants9 generations forward: 13 descendants10 generations forward: 10 descendants11 generations forward: 2 descendants12 generations forward: 1 descendant13 generations forward: 1 descendant K072253 · Synfix-LR Spacer · Synthes Spine Co.Lp · 2007 · recalledK062083 · Synfix -LR · Synthes Spine Co.Lp · 2007K010530 · Geo Structure · Interpore Cross Intl. · 20010+5+10
  1. Root · 3 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
  2. 2 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
  3. 1 generation backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
  4. This deviceK072981 Synthes Zero-PSynthes Spine Co.Lp · 2008
  5. Descendant · cites it directly · 346 of its ownK100698 STCCCardinal Spine, LLC · 2011
  6. Descendant · 2 generations on · 345 of its ownK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
  7. Descendant · 3 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
  8. Descendant · 4 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
  9. Descendant · cites it directly · 306 of its ownK093762 Synthes Zero-PSynthes Spine · 2010 · Recalled

Showing 5 of 546 descendants. See all descendants

Descendants cleared per year

2010: 32011: 82012: 32013: 32014: 52015: 132016: 172017: 322018: 292019: 342020: 502021: 482022: 562023: 702024: 602025: 612026: 54
2010high 70 (2023) · low 3 (2010)2026

Most influential descendants

Showing 5 of 546 · See all
  • K100698STCCCardinal Spine, LLC · 2011 · cites it directly346descendants
  • K111439Chesapeake (Cervical Components)K2m, Inc. · 2011 · 2 generations on345descendants
  • K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 3 generations on330descendants
  • K160125Cascadia Interbody SystemK2m · 2016 · 4 generations on315descendants
  • K093762Synthes Zero-PSynthes Spine · 2010 · cites it directly306descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010530Geo StructureInterpore Cross Intl.2001—
−2K062083Synfix -LRSynthes Spine Co.Lp2007—
−1K072253Synfix-LR SpacerSynthes Spine Co.Lp20071
0 (this device)K072981Synthes Zero-PSynthes Spine Co.Lp2008—
+1K100698STCCCardinal Spine, LLC2011—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20111
+3K133494Chesapeake Spinal SystemK2m, Inc.2014—
+4K160125Cascadia Interbody SystemK2m2016—
+1K093762Synthes Zero-PSynthes Spine20101

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201180
201230
201330
201450
2015130
2016170
2017320
2018290
2019340
2020500
2021480
2022560
2023700
2024600
2025610
2026540
FIG. 1 — Lineage of K072981, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…Class 11 (special controls) Orthopaedic and Rehabilitation Devices Panel (87) Product Code ODP (Intervertebral Fusion Device with Bone Graft, Cervical) : Predicates: P980048 BAK/Cervical Interbody Fusion Device (Sulzer Spine-Tech) P000028 Affinity Anterior Cervical Cage System (Medtronic Vascular) K072…
Sulzer Spine-Tech2001—
*P000028Affinity (TM) Cage System
Summary page 1
…es Panel (87) Product Code ODP (Intervertebral Fusion Device with Bone Graft, Cervical) : Predicates: P980048 BAK/Cervical Interbody Fusion Device (Sulzer Spine-Tech) P000028 Affinity Anterior Cervical Cage System (Medtronic Vascular) K072253 SynFix-LR (Synthes Spine) K011037 Vertebral Spacer (Synthes…
Medtronic Sofamor Danek USA, Inc.2002—
*K072253Synfix-LR Spacer
Summary page 1
…one Graft, Cervical) : Predicates: P980048 BAK/Cervical Interbody Fusion Device (Sulzer Spine-Tech) P000028 Affinity Anterior Cervical Cage System (Medtronic Vascular) K072253 SynFix-LR (Synthes Spine) K011037 Vertebral Spacer (Synthes Spine) Device Description: The Synthes Zero-P is a radiolucent and…
Synthes Spine Co.Lp20071
*K011037Vertebral Spacer
Summary page 1
…P980048 BAK/Cervical Interbody Fusion Device (Sulzer Spine-Tech) P000028 Affinity Anterior Cervical Cage System (Medtronic Vascular) K072253 SynFix-LR (Synthes Spine) K011037 Vertebral Spacer (Synthes Spine) Device Description: The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral…
Synthes (Usa)2002—

Also cleared against P980048: 53 other devices →

What descends from it? (546)

See all 546

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

NumberDeviceApplicantDecidedDescendants
K100698STCCCardinal Spine, LLC2011346
K093762Synthes Zero-PSynthes Spine2010306
K112459Synthes Zero-PSynthes Spine Co.Lp2011277
K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173
K092521ZUMA-CSeaspine, Inc.2010168
K152532AERO -C Cervical Cage SystemStryker Spine2015145
K113796Solitaire-C Cervical Spacer SystemEbi, LLC2012142
K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137
K102547Coroent Interlock SystemNuvasive, Inc.2011131
K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 23, 2011Not classifiedZ-0104-2012Labeling False and MisleadingLABELING 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…
Feb 10, 2009Not classifiedZ-1348-2009Labeling designTip 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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K100698 (Cardinal Spine, LLC, 2011) has gone furthest, with 346 descendants of its own.
  • 53 other devices also cite its predicate P980048.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

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

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
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

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

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-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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against P980048

53 other devices cite the same predicate.

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K182477Cervical SpacerAdditive Implants, LLC · 2019
  • K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018

More from Synthes Spine Co.Lp

18 FDA decisions under this applicant name. See the company

  • K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
  • K112459Synthes Zero-PSynthes Spine Co.Lp · 2011
  • K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 20111 recall
  • K103320Synthes XRLSynthes Spine Co.Lp · 20111 recall
  • K081568Antegra-TSynthes Spine Co.Lp · 2008

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K072981 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072981: Synthes Zero-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072981

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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