FDA product code FWP: Prosthesis, Chin, Internal
FWP is the FDA product code for prosthesis, chin, internal. It is a Class II device, regulated under 21 CFR 878.3550 and reviewed by the General and Plastic Surgery panel. FDA has cleared 66 510(k) submissions under FWP, 2 in the last five years, from 32 different applicants. The average 510(k) review took 98 days (median 70); 73 days on average over the last three years. FDA has posted 5 recalls for FWP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Chin, Internal |
| Device class | Class II |
| Regulation | 21 CFR 878.3550 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FWP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 72 |
| 2020 | 1 | 289 |
| 2023 | 1 | 89 |
| 2026 | 1 | 73 |
Compare with all 510(k) review times · Search every FWP clearance
Top FWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implantech Associates, Inc. | 16 | 2020-12-23 |
| Spectrum Designs, Inc. | 7 | 1998-05-06 |
| Byron Medical | 4 | 1991-02-19 |
| W. L. Gore & Associates, Inc. | 3 | 1995-03-22 |
| Stryker Leibinger GmbH & Co KG | 2 | 2026-03-12 |
27 more applicants have FWP clearances. See the full list in Caduvo.
Most recent FWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254233 | Stryker Leibinger GmbH & Co KG | MEDPOR Customized Implant Kit | 2026-03-12 | 73 |
| K232593 | Keosan Trading Co. | FITme Customized Silicone Implant | 2023-11-22 | 89 |
| K200610 | Implantech Associates, Inc. | Customized Contour Implant | 2020-12-23 | 289 |
| K191130 | Implantech Associates, Inc. | Customized Contour Implant | 2019-08-23 | 116 |
| K191916 | Stryker Leibinger GmbH & Co KG | Stryker CMF MEDPOR Priority Customized Implant Kit | 2019-08-15 | 29 |
Recalls for FWP devices
5 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code FWP?
FWP is the FDA product code for prosthesis, chin, internal. It is a Class II device, regulated under 21 CFR 878.3550 and reviewed by the General and Plastic Surgery panel.
What device class is FWP?
Class II, regulation 21 CFR 878.3550. Typical premarket route: 510(k).
How long does a 510(k) take for product code FWP?
Across 66 cleared submissions the average was 98 days from receipt to decision (median 70).
Which companies have the most FWP clearances?
Implantech Associates, Inc. (16); Spectrum Designs, Inc. (7); Byron Medical (4); W. L. Gore & Associates, Inc. (3); Stryker Leibinger GmbH & Co KG (2).
Have FWP devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code FWP
- Run a recall and safety report across every FWP manufacturer
- Watch product code FWP 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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