Product code JWH: 510(k) clearances and predicates
Product code JWH covers GMK Extension. FDA lists 921 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
921 clearances on file under product code JWH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 17 |
| 2023 | 20 |
| 2024 | 19 |
| 2025 | 20 |
| 2026 so far | 12 |
Recent clearances
Newest JWH clearances in the FDA index, with applicant and decision date:
- K262057, GMK Extension, applicant Medacta International SA, decided 2026-09-15. FDA record
- K260063, GSPE Spacer, applicant The General Hospital Corporation, d/b/a Massachusetts, decided 2026-09-11. FDA record
- K262293, EVOLUTION MPX Total Knee System, applicant Suzhou Microport Orthorecon Co., Ltd., decided 2026-09-10. FDA record
- K262341, b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions, applicant B-One Ortho, Corp., decided 2026-09-08. FDA record
- K262130, ATTUNE Revision Knee System, applicant Depuy Orthopaedics, Inc., decided 2026-09-04. FDA record
- K253961, SK Knee System, applicant Just Medical Devices (Tianjin) Co., Ltd., decided 2026-09-01. FDA record
- K261563, Freedom Total Knee System (E-Poly Tibial Liners), applicant Maxx Orthopedics, Inc., decided 2026-08-07. FDA record
- K262251, ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert), applicant Globus Medical, Inc., decided 2026-07-31. 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 GSPE Spacer, EVOLUTION MPX Total Knee System. Watch new JWH 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 JWH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JWH clearances include GMK Extension.
How many 510(k) clearances use product code JWH?
921 at the time this page was generated, from openFDA records.
How do I find a predicate device under JWH?
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 JWH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.