FDA product code · Orthopedic
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
Product code MAX covers Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II device regulated under 21 CFR 888.3080. FDA has cleared 894 devices in this code, 22 of them in the last 12 months. Median review time across the 894 most recent decisions is 106 days. openFDA lists 115 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3080
- Review panel
- Orthopedic
- Clearances
- 894
What is happening in MAX right now?
MAX (Intervertebral Fusion Device With Bone Graft, Lumbar) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-0892-2026, Z-0895-2026, Z-1038-2026, Z-1039-2026, Z-0580-2026). 6 first-time filers in the last 12 months, including Beijing Fule Science & Technology Development Co., Ltd. and Global Biomedica s.r.o (K253151, K253894, K254017, K253583, K252351). The code is crowded, scoring 100 of 100 — 254 companies hold a clearance here and 22 arrived in the last 12 months (MAX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0892-2026, Z-0895-2026, Z-1038-2026, Z-1039-2026, Z-0580-2026 |
| New entrant | Worth knowing | K253151, K253894, K254017, K253583, K252351 |
| Crowding | Context | MAX: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 MAX cover?
MAX is FDA's product code for Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II device regulated under 21 CFR 888.3080.
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Source: openFDA device/classification · record MAX · retrieved
How many devices has FDA cleared in MAX?
FDA has cleared 894 devices under product code MAX since the 510(k) programme began in 1976, 22 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | |
| K261020 | Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. | |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | Carlsmed, Inc. | |
| K261067 | BEE PLIF Cage | NGMedical GmbH |
How long does FDA review take for MAX?
The median FDA review time for MAX is 106 days, measured across the 894 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 MAX?
openFDA lists 115 recall records against product code MAX. A recall record covers one firm's corrective action and may span many device lots.
Z-0892-2026Open, ClassifiedOrthofix U.S. LLC
Labeling contains claims that are not consistently present.
Z-0895-2026Open, ClassifiedOrthofix U.S. LLC
Labeling contains claims that are not consistently present.
Z-1038-2026Open, ClassifiedMedicrea International
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Z-1039-2026Open, ClassifiedMedicrea International
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Z-0580-2026Open, ClassifiedMedtronic Sofamor Danek USA, Inc
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Showing the 5 most recently initiated of 115. 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 MAX?
MAUDE holds 2,160 adverse-event reports naming product code MAX, 465 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 MAX unusual?
Every month with enough history behind it falls inside MAX's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 44 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 154 | Insufficient history | No expected range — too little history | |
| 64 | Insufficient history | No expected range — too little history | |
| 56 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 70 | Insufficient history | No expected range — too little history | |
| 80 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 57 | Insufficient history | No expected range — too little history | |
| 78 | 0–119 | Within expected (0–119) | |
| 63 | 25–81 | Within expected (25–81) | |
| 89 | 30–96 | Within expected (30–96) | |
| 84 | 32–114 | Within expected (32–114) | |
| 54 | 32–110 | Within expected (32–110) | |
| 82 | 33–104 | Within expected (33–104) | |
| 57 | 63–166 | Below expected (63–166) | |
| 60 | 34–113 | Within expected (34–113) | |
| 65 | 34–113 | Within expected (34–113) | |
| 59 | 30–111 | Within expected (30–111) | |
| 41 | 22–98 | Within expected (22–98) | |
| 63 | 15–106 | Within expected (15–106) | |
| 50 | 18–124 | Within expected (18–124) | |
| 54 | 8–101 | Within expected (8–101) | |
| 87 | 10–110 | Within expected (10–110) |
21 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 MAX.
Who has entered MAX in the last year?
6 companies filed in MAX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Beijing Fule Science & Technology Development Co., Ltd. | K253151 | |
| Global Biomedica s.r.o. | K253894 | |
| Implanet | K254017 | |
| Xenix Medical | K253583 | |
| Cg Medtech Co., Ltd. | K252351 | |
| Mobarn Medical Devices, LLC | K251479 |
"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 MAX?
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 MAX?
Across the 894 most recent decisions, these applicants filed most often in MAX.
| Applicant | Recent clearances |
|---|---|
| Nu Vasive, Incorporated | 34 |
| Medtronic Sofamor Danek USA, Inc. | 33 |
| Life Spine, Inc. | 26 |
| Spineology, Inc. | 22 |
| Globus Medical, Inc. | 20 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in MAX 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 |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc | 37 | 2 |
| Life Spine, Inc. | 32 | 2 |
| Alphatec Spine, Inc. | 21 | 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 MAX
Get an email the morning anything changes in MAX — 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.