Product code KTT: 510(k) clearances and predicates
Product code KTT covers MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System. FDA lists 404 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
404 clearances on file under product code KTT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 7 |
| 2024 | 5 |
| 2025 | 10 |
| 2026 so far | 4 |
Recent clearances
Newest KTT clearances in the FDA index, with applicant and decision date:
- K254087, MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System, applicant Synthes (USA) Products, LLC, decided 2026-06-11. FDA record
- K260900, DYNEX® External Fixation Systems, applicant Vilex, LLC, decided 2026-04-17. FDA record
- K260112, QuikFix External Fixator: Knee-Spanning Pack, applicant Stabiliz Orthopaedics, Inc., decided 2026-03-23. FDA record
- K253291, Excelsior System, applicant Blue Ocean Global, decided 2026-01-20. FDA record
- K253613, Monkey Rings External Ring Fixation System, applicant Paragon 28, Inc., decided 2025-12-19. FDA record
- K253202, Hoffmann LRF System, applicant Stryker GmbH, decided 2025-12-19. FDA record
- K252555, Medusa Orthopedics Boa External Fixation System, applicant Medusa Orthopedics, LLC, decided 2025-11-25. FDA record
- K252625, The Response Ortho Smart Fixator - Hexapod System, applicant Response Ortho Solutions, LLC, decided 2025-11-20. 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 DYNEX® External Fixation Systems, QuikFix External Fixator: Knee-Spanning Pack. Watch new KTT 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 KTT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KTT clearances include MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System.
How many 510(k) clearances use product code KTT?
404 at the time this page was generated, from openFDA records.
How do I find a predicate device under KTT?
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 KTT clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.