FDA product code KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWT is the FDA product code for prosthesis, shoulder, non-constrained, metal/polymer cemented. It is a Class II device, regulated under 21 CFR 888.3650 and reviewed by the Orthopedic panel. FDA has cleared 72 510(k) submissions under KWT, 8 in the last five years, from 33 different applicants. The average 510(k) review took 130 days (median 90); 184 days on average over the last three years. FDA has posted 31 recalls for KWT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3650 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 133 |
| 2018 | 2 | 70 |
| 2019 | 4 | 92 |
| 2020 | 1 | 387 |
| 2021 | 1 | 87 |
| 2022 | 1 | 42 |
| 2023 | 1 | 219 |
| 2024 | 1 | 254 |
| 2025 | 4 | 225 |
| 2026 | 1 | 74 |
Compare with all 510(k) review times · Search every KWT clearance
Top KWT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 11 | 2011-12-15 |
| Zimmer, Inc. | 6 | 2012-10-11 |
| Intermedics Orthopedics | 5 | 1997-02-27 |
| Exactech, Inc. | 4 | 2025-12-01 |
| Catalyst Orthoscience, Inc. | 4 | 2019-09-11 |
28 more applicants have KWT clearances. See the full list in Caduvo.
Most recent KWT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262173 | Shoulder Innovations, Inc. | N22 Offset Humeral Head | 2026-09-08 | 74 |
| K250713 | Exactech, Inc. | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | 2025-12-01 | 266 |
| K251686 | Tornier, Inc. | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | 2025-10-30 | 150 |
| K241944 | Implantcast GmbH | AGILON® XO Shoulder Replacement System | 2025-03-10 | 251 |
| K241817 | Shoulder Innovations, Inc. | InSet Total Shoulder System | 2025-02-11 | 232 |
Recalls for KWT devices
31 product recalls in 20 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2023-11-21.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code KWT?
KWT is the FDA product code for prosthesis, shoulder, non-constrained, metal/polymer cemented. It is a Class II device, regulated under 21 CFR 888.3650 and reviewed by the Orthopedic panel.
What device class is KWT?
Class II, regulation 21 CFR 888.3650. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWT?
Across 72 cleared submissions the average was 130 days from receipt to decision (median 90).
Which companies have the most KWT clearances?
Biomet, Inc. (11); Zimmer, Inc. (6); Intermedics Orthopedics (5); Exactech, Inc. (4); Catalyst Orthoscience, Inc. (4).
Have KWT devices been recalled?
Yes: 31 product recalls across 20 recall events; the most recent began 2023-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code KWT
- Run a recall and safety report across every KWT manufacturer
- Watch product code KWT 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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