FDA product code KWD: Prosthesis, Toe, Hemi-, Phalangeal
KWD is the FDA product code for prosthesis, toe, hemi-, phalangeal. It is a Class II device, regulated under 21 CFR 888.3730 and reviewed by the Orthopedic panel. FDA has cleared 46 510(k) submissions under KWD, 5 in the last five years, from 27 different applicants. The average 510(k) review took 152 days (median 92); 238 days on average over the last three years. FDA has posted 13 recalls for KWD devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Toe, Hemi-, Phalangeal |
| Device class | Class II |
| Regulation | 21 CFR 888.3730 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 271 |
| 2019 | 2 | 138 |
| 2020 | 1 | 243 |
| 2021 | 1 | 53 |
| 2022 | 2 | 392 |
| 2023 | 1 | 357 |
| 2024 | 1 | 29 |
| 2026 | 1 | 448 |
Compare with all 510(k) review times · Search every KWD clearance
Top KWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrosurface, Inc. | 5 | 2019-08-14 |
| Solana Surgical, LLC | 4 | 2013-10-22 |
| Biopro, Inc. | 3 | 2012-10-30 |
| Vilex, Inc. | 3 | 2011-07-20 |
| Osteomed LP | 3 | 2008-08-01 |
22 more applicants have KWD clearances. See the full list in Caduvo.
Most recent KWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250074 | Hyalex Orthopaedics, Inc. | HYALEX® MTP Hemiarthroplasty Implant | 2026-04-03 | 448 |
| K240268 | Accufix Surgical, Inc. | Accu-Joint Hemi Implant | 2024-02-29 | 29 |
| K221220 | Montross Extremity Medical | Montross Extremity Medical Hemi Implant System | 2023-04-19 | 357 |
| K222964 | BioPoly, LLC | BioPoly Lesser Toe Hemiarthroplasty Implant | 2022-11-22 | 56 |
| K201393 | Restor3D, Inc. | restor3d MTP Implant | 2022-05-25 | 728 |
Recalls for KWD devices
13 product recalls in 4 recall events; 10 initiated in the last five years and 0 still open. Most recent: 2022-02-01.
| Year | Recalls |
|---|---|
| 2022 | 10 |
Frequently asked questions
What is FDA product code KWD?
KWD is the FDA product code for prosthesis, toe, hemi-, phalangeal. It is a Class II device, regulated under 21 CFR 888.3730 and reviewed by the Orthopedic panel.
What device class is KWD?
Class II, regulation 21 CFR 888.3730. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWD?
Across 46 cleared submissions the average was 152 days from receipt to decision (median 92).
Which companies have the most KWD clearances?
Arthrosurface, Inc. (5); Solana Surgical, LLC (4); Biopro, Inc. (3); Vilex, Inc. (3); Osteomed LP (3).
Have KWD devices been recalled?
Yes: 13 product recalls across 4 recall events; the most recent began 2022-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code KWD
- Run a recall and safety report across every KWD manufacturer
- Watch product code KWD 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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