FDA product code · Orthopedic · Class 2
MAX: Intervertebral Fusion Device With Bone Graft, Lumbar
MAX is FDA's product code for "Intervertebral Fusion Device With Bone Graft, Lumbar": a Class 2 device classified under 21 CFR 888.3080, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for MAX
Across 388 510(k) clearances under MAX decided from 2018-01-01 to 2026-10-06, the median was 106 days from FDA receipt to decision. Half took between 60 and 170 days, and 80% were decided within 191 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 60 |
| Median | 106 |
| 75th percentile | 170 |
| 80th percentile | 191 |
| 90th percentile | 262 |
| Slowest | 627 |
| Year | Median days | n |
|---|---|---|
| 2018 | 114 | 64 |
| 2019 | 131 | 60 |
| 2020 | 106 | 56 |
| 2021 | 109 | 53 |
| 2022 | 95 | 41 |
| 2023 | 87 | 30 |
| 2024 | 91 | 38 |
| 2025 | 85 | 29 |
| 2026 (to 10-06, partial) | 98 | 17 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MAX in the public FDA record
| 510(k) clearances, all years | 896 |
|---|---|
| Device recalls | 115 |
| Establishment listings | 3,046 |
| GUDID device identifiers | 174,971 |
Counts of records, not of devices or events. Adverse event reports for MAX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MAX
14 FDA recognized consensus standards cite MAX, among them ASTM F2267-04 (Reapproved 2018); ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-185 ASTM F2267-04 (Reapproved 2018) — Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-347 ASTM F2077-18 — Test Methods for Intervertebral Body Fusion Devices
- 11-369 ASTM F3292-19 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 11-390 ISO 23089-2 First edition 2021-05 — Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
- 11-418 ASTM F3631-24 — Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
- 11-421 ASTM F2077-24 — Standard Test Methods for Intervertebral Body Fusion Devices
- 11-423 ASTM F2267-24 — Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-435 ASTM F3292-25 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 8-558 ASTM F3333-20 — Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 8-577 ISO 13179-1 Second Edition 2021-09 — Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.