Product code KWS: 510(k) clearances and predicates
Product code KWS covers Tornier Perform Advanced Glenoid. FDA lists 191 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
191 clearances on file under product code KWS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 so far | 2 |
Recent clearances
Newest KWS clearances in the FDA index, with applicant and decision date:
- K260721, Tornier Perform Advanced Glenoid, applicant Tornier, Inc., decided 2026-07-22. FDA record
- K254084, AETOS Shoulder System - CONCELOC Glenoids, applicant Smith & Nephew, Inc., decided 2026-04-06. FDA record
- K252418, Catalyst F1x Shoulder System, applicant Catalyst Orthoscience, Inc., decided 2025-11-06. FDA record
- K252416, AETOS Shoulder System Meta Humeral Prosthesis Size 0, applicant Smith & Nephew, Inc., decided 2025-10-29. FDA record
- K241292, MyShoulder Planner (5.3SSWPL), applicant Medacta International S.A., decided 2025-01-30. FDA record
- K241878, Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem), applicant Stryker Corporation (Tornier, Inc.), decided 2024-12-06. FDA record
- K241609, Tornier Humeral Reconstruction System (Tornier HRS), applicant Stryker Corporation (Tornier, Inc.), decided 2024-09-10. FDA record
- K230513, Arthrex Univers Apex OptiFit Humeral Stem, applicant Arthrex, Inc., decided 2023-09-26. 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 AETOS Shoulder System - CONCELOC Glenoids, Catalyst F1x Shoulder System. Watch new KWS 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 KWS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KWS clearances include Tornier Perform Advanced Glenoid.
How many 510(k) clearances use product code KWS?
191 at the time this page was generated, from openFDA records.
How do I find a predicate device under KWS?
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 KWS clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for KWS, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free KWS brief
Tell us where to send it. No card required.
You are on the list.
We will email your free KWS brief shortly. KWS is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.