FDA product code KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWS is the FDA product code for prosthesis, shoulder, semi-constrained, metal/polymer cemented. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel. FDA has cleared 191 510(k) submissions under KWS, 16 in the last five years, from 60 different applicants. The average 510(k) review took 117 days (median 98); 135 days on average over the last three years. FDA has posted 153 recalls for KWS devices, 26 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3660 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 111 |
| 2018 | 4 | 168 |
| 2019 | 9 | 111 |
| 2020 | 3 | 102 |
| 2021 | 5 | 150 |
| 2022 | 5 | 167 |
| 2023 | 4 | 225 |
| 2024 | 2 | 129 |
| 2025 | 3 | 151 |
| 2026 | 2 | 124 |
Compare with all 510(k) review times · Search every KWS clearance
Top KWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 15 | 2023-09-26 |
| Tornier, Inc. | 12 | 2026-07-22 |
| Tornier | 12 | 2011-11-03 |
| Smith & Nephew, Inc. | 11 | 2026-04-06 |
| Encore Medical L.P. | 9 | 2023-06-23 |
55 more applicants have KWS clearances. See the full list in Caduvo.
Most recent KWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260721 | Tornier, Inc. | Tornier Perform Advanced Glenoid | 2026-07-22 | 139 |
| K254084 | Smith & Nephew, Inc. | AETOS Shoulder System - CONCELOC Glenoids | 2026-04-06 | 109 |
| K252418 | Catalyst Orthoscience, Inc. | Catalyst F1x Shoulder System | 2025-11-06 | 97 |
| K252416 | Smith & Nephew, Inc. | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | 2025-10-29 | 89 |
| K241292 | Medacta International S.A. | MyShoulder Planner (5.3SSWPL) | 2025-01-30 | 267 |
Recalls for KWS devices
153 product recalls in 52 recall events; 26 initiated in the last five years and 27 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 11 |
| 2021 | 2 |
| 2023 | 5 |
| 2024 | 14 |
| 2025 | 4 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code KWS?
KWS is the FDA product code for prosthesis, shoulder, semi-constrained, metal/polymer cemented. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel.
What device class is KWS?
Class II, regulation 21 CFR 888.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWS?
Across 191 cleared submissions the average was 117 days from receipt to decision (median 98).
Which companies have the most KWS clearances?
Arthrex, Inc. (15); Tornier, Inc. (12); Tornier (12); Smith & Nephew, Inc. (11); Encore Medical L.P. (9).
Have KWS devices been recalled?
Yes: 153 product recalls across 52 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KWS
- Run a recall and safety report across every KWS manufacturer
- Watch product code KWS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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