FDA product code · Orthopedic
ODPIntervertebral Fusion Device With Bone Graft, Cervical
Product code ODP covers Intervertebral Fusion Device With Bone Graft, Cervical, a Class II device regulated under 21 CFR 888.3080. FDA has cleared 352 devices in this code, 24 of them in the last 12 months. Median review time across the 352 most recent decisions is 117 days. openFDA lists 11 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3080
- Review panel
- Orthopedic
- Clearances
- 352
What is happening in ODP right now?
ODP (Intervertebral Fusion Device With Bone Graft, Cervical) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class III) (Z-0891-2026, Z-0896-2026). 12 first-time filers in the last 12 months, including Fims Co., Ltd. and C.A. Medical, LLC (K253041, K254130, K260850, K260340, K242303). The code is crowded, scoring 99 of 100 — 184 companies hold a clearance here and 24 arrived in the last 12 months (ODP:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class III recall | Z-0891-2026, Z-0896-2026 |
| New entrant | Worth knowing | K253041, K254130, K260850, K260340, K242303 |
| Crowding | Context | ODP:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code ODP cover?
ODP is FDA's product code for Intervertebral Fusion Device With Bone Graft, Cervical, a Class II device regulated under 21 CFR 888.3080.
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Source: openFDA device/classification · record ODP · retrieved
How many devices has FDA cleared in ODP?
FDA has cleared 352 devices under product code ODP since the 510(k) programme began in 1976, 24 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | |
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | |
| K253260 | ORIO-3D Cage System | SpineCraft | |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | |
| K242303 | MOD-C | Orthomod, LLC | |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine |
How long does FDA review take for ODP?
The median FDA review time for ODP is 117 days, measured across the 352 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in ODP?
openFDA lists 11 recall records against product code ODP. A recall record covers one firm's corrective action and may span many device lots.
Z-0891-2026Open, ClassifiedOrthofix U.S. LLC
Labeling contains claims that are not consistently present.
Z-0896-2026Open, ClassifiedOrthofix U.S. LLC
Labeling contains claims that are not consistently present.
Z-2456-2023Open, ClassifiedMedicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-2460-2023Open, ClassifiedMedicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-2462-2023Open, ClassifiedMedicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Showing the 5 most recently initiated of 11. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for ODP?
MAUDE holds 158 adverse-event reports naming product code ODP, 38 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in ODP unusual?
Every month with enough history behind it falls inside ODP's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 4 | 0–12 | Within expected (0–12) | |
| 8 | 0–9 | Within expected (0–9) | |
| 8 | 1–12 | Within expected (1–12) | |
| 3 | 1–13 | Within expected (1–13) | |
| 3 | 0–11 | Within expected (0–11) | |
| 3 | 0–11 | Within expected (0–11) | |
| 1 | 0–16 | Within expected (0–16) | |
| 5 | 0–12 | Within expected (0–12) | |
| 12 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
25 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in ODP.
Who has entered ODP in the last year?
8 companies filed in ODP for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Fims Co., Ltd. | K253041 | |
| C.A. Medical, LLC | K254130 | |
| Osteomni, Inc. | K260850 | |
| HC Biologics, LLC | K260340 | |
| Orthomod, LLC | K242303 | |
| Spinepoint, LLC | K252432 | |
| NanoHive Medical, LLC | K254105 | |
| Sync Surgical | K252219 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in ODP?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in ODP?
Across the 352 most recent decisions, these applicants filed most often in ODP.
| Applicant | Recent clearances |
|---|---|
| Orthofix, Inc. | 9 |
| Nu Vasive, Incorporated | 8 |
| Gbs Commonwealth Co., Ltd. | 7 |
| Globus Medical, Inc. | 7 |
| Medtronic Sofamor Danek USA, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in ODP file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Orthofix, Inc. | 10 | 2 |
| Medtronic Sofamor Danek USA, Inc | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch ODP
Get an email the morning anything changes in ODP — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.