510(k) Report

FDA product code · Orthopedic

Intervertebral Fusion Device With Bone Graft, Cervical

ODPClass II21 CFR 888.3080510(k) required354 decisions since 20086 recalls

354 FDA decisions since 2008. 510(k) reviews decided 2021–2025 took a median of 116 days (half between 64 and 241). 6 recalls name this code, 0 of them Class I. The most-cited predicate is K091088, named by 51 later devices.

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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

FIG. A — Illustration, orthopedic panel

Twenty years of ODP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—
FIG. 1 — ODP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ODP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do ODP devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 200951cite it
  • K073351CrystalSpinal Elements, Inc. · 200827cite it
  • K160125Cascadia Interbody SystemK2m · 201621cite it
  • K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 201121cite it
  • K081611Nuvasive Coroent SystemNuvasive, Inc. · 200818cite it
  • K081730Novel Cervical Spinal Spacer SystemAlphatec Spine, Inc. · 200816cite it

Which ODP devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K252894aprevo® cervical interbody systemCarlsmed, Inc. · 202634generations
  • K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC · 202633generations
  • K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc. · 202533generations
  • K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 202532generations
  • K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva…Curiteva, Inc. · 202631generations
  • K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 202431generations

What has FDA decided in ODP lately?

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026
  • K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026

All 354 ODP decisions →

What has been recalled in ODP lately?

  • K172437Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer…Orthofix U.S. LLC · Nov 3, 2025Class III
  • K203342Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer…Orthofix U.S. LLC · Nov 3, 2025Class III
  • K173832XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single…XTANT Medical · Sep 30, 2020Class III
  • K073177C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless…RTI Surgical, Inc. · Oct 7, 2013Class II
  • K072981Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody…Synthes USA (HQ), Inc. · Sep 23, 2011
  • K072981Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use…Synthes Spine · Feb 10, 2009

Related product codes

Other codes under 21 CFR 888.3080.

MAX Intervertebral Fusion Device With Bone Graft…OVE Intervertebral Fusion Device With Integrated…OVD Intervertebral Fusion Device With Integrated…PHM Intervertebral Fusion Device With Bone Graft…