FDA product code KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer
KWI is the FDA product code for prosthesis, elbow, hemi-, radial, polymer. It is a Class II device, regulated under 21 CFR 888.3170 and reviewed by the Orthopedic panel. FDA has cleared 34 510(k) submissions under KWI, 4 in the last five years, from 23 different applicants. The average 510(k) review took 137 days (median 116); 140 days on average over the last three years. FDA has posted 30 recalls for KWI devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3170 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 107 |
| 2019 | 1 | 142 |
| 2020 | 1 | 99 |
| 2021 | 1 | 99 |
| 2022 | 1 | 129 |
| 2023 | 1 | 155 |
| 2024 | 1 | 126 |
| 2026 | 1 | 154 |
Compare with all 510(k) review times · Search every KWI clearance
Top KWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 4 | 2006-04-19 |
| Avanta Orthopaedics, Inc. | 4 | 2002-11-27 |
| Biomet, Inc. | 3 | 2005-08-05 |
| In2bones USA, LLC | 2 | 2021-12-17 |
| Skeletal Dynamics, LLC | 2 | 2017-12-22 |
18 more applicants have KWI clearances. See the full list in Caduvo.
Most recent KWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260624 | Arthrex, Inc. | Arthrex Radial Head Replacement System | 2026-07-30 | 154 |
| K233592 | BioPoly, LLC | BioPoly Radial Head Implant | 2024-03-13 | 126 |
| K231188 | Skeletal Dynamics, Inc. | ALIGN Radial Head System | 2023-09-28 | 155 |
| K213563 | DePuy Synthes | DePuy Synthes Radial Head Replacement System | 2022-03-18 | 129 |
| K212872 | In2bones USA, LLC | Avenger Radial Head System | 2021-12-17 | 99 |
Recalls for KWI devices
30 product recalls in 12 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-08-03.
| Year | Recalls |
|---|---|
| 2017 | 19 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 3 |
Frequently asked questions
What is FDA product code KWI?
KWI is the FDA product code for prosthesis, elbow, hemi-, radial, polymer. It is a Class II device, regulated under 21 CFR 888.3170 and reviewed by the Orthopedic panel.
What device class is KWI?
Class II, regulation 21 CFR 888.3170. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWI?
Across 34 cleared submissions the average was 137 days from receipt to decision (median 116).
Which companies have the most KWI clearances?
Wrightmedicaltechnologyinc (4); Avanta Orthopaedics, Inc. (4); Biomet, Inc. (3); In2bones USA, LLC (2); Skeletal Dynamics, LLC (2).
Have KWI devices been recalled?
Yes: 30 product recalls across 12 recall events; the most recent began 2022-08-03.
Next steps
- Run an FDA pathway report with predicate devices for product code KWI
- Run a recall and safety report across every KWI manufacturer
- Watch product code KWI 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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