Product code MAX: 510(k) clearances and predicates
Product code MAX covers SCALA® TL. FDA lists 896 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
896 clearances on file under product code MAX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 41 |
| 2023 | 30 |
| 2024 | 38 |
| 2025 | 29 |
| 2026 so far | 17 |
Recent clearances
Newest MAX clearances in the FDA index, with applicant and decision date:
- K261049, SCALA® TL, applicant Spineart SA, decided 2026-08-20. FDA record
- K261430, TruLift Expandable System, applicant Life Spine, Inc., decided 2026-07-28. FDA record
- K253011, Catalyft PL Expandable Interbody System, applicant Medtronic Sofamor Danek USA, Inc., decided 2026-07-17. FDA record
- K261020, Symmetrix L Spinal System, applicant Medtronic Sofamor Danek USA, Inc., decided 2026-07-14. FDA record
- 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, applicant SeaSpine Orthopedics Corporation, decided 2026-07-01. FDA record
- K253151, Fule Interbody Fusion Cage System, applicant Beijing Fule Science & Technology Development Co., Ltd., decided 2026-06-15. FDA record
- K261159, Exceed® Biplanar Expandable Interbody System, applicant Spine Wave, Inc., decided 2026-05-29. FDA record
- K253894, BMD Titanium Spinal Fusion System, applicant Global Biomedica s.r.o., decided 2026-05-28. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include TruLift Expandable System, Catalyft PL Expandable Interbody System. Watch new MAX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MAX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MAX clearances include SCALA® TL.
How many 510(k) clearances use product code MAX?
896 at the time this page was generated, from openFDA records.
How do I find a predicate device under MAX?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MAX clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.