FDA product code KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWY is the FDA product code for prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented. It is a Class II device, regulated under 21 CFR 888.3390 and reviewed by the Orthopedic panel. FDA has cleared 99 510(k) submissions under KWY, 6 in the last five years, from 63 different applicants. The average 510(k) review took 140 days (median 90); 234 days on average over the last three years. FDA has posted 88 recalls for KWY devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3390 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 3 | 236 |
| 2019 | 5 | 137 |
| 2020 | 1 | 30 |
| 2022 | 2 | 29 |
| 2023 | 2 | 168 |
| 2025 | 1 | 273 |
| 2026 | 1 | 195 |
Compare with all 510(k) review times · Search every KWY clearance
Top KWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Johnson & Johnson Professionals, Inc. | 9 | 1998-12-04 |
| Biomet, Inc. | 5 | 2005-12-16 |
| Ortho Development Corp. | 5 | 2005-07-07 |
| Howmedica Corp. | 4 | 1994-03-01 |
| 3M Company | 4 | 1990-01-19 |
58 more applicants have KWY clearances. See the full list in Caduvo.
Most recent KWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253357 | B-One Ortho, Corp. | b-ONE® Bipolar Head | 2026-04-13 | 195 |
| K243634 | Maxx Orthopedics, Inc. | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | 2025-08-25 | 273 |
| K231526 | Depuy Ireland UC | CORAIL Cemented Femoral Stem | 2023-12-19 | 207 |
| K223441 | G21, S.R.L. | SpaceFlex Acetabular Cup | 2023-03-23 | 129 |
| K221794 | Waldemar Link GmbH & Co. KG | Vario-Cup System | 2022-07-20 | 29 |
Recalls for KWY devices
88 product recalls in 23 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-09-23.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 20 |
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code KWY?
KWY is the FDA product code for prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented. It is a Class II device, regulated under 21 CFR 888.3390 and reviewed by the Orthopedic panel.
What device class is KWY?
Class II, regulation 21 CFR 888.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWY?
Across 99 cleared submissions the average was 140 days from receipt to decision (median 90).
Which companies have the most KWY clearances?
Johnson & Johnson Professionals, Inc. (9); Biomet, Inc. (5); Ortho Development Corp. (5); Howmedica Corp. (4); 3M Company (4).
Have KWY devices been recalled?
Yes: 88 product recalls across 23 recall events; the most recent began 2025-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KWY
- Run a recall and safety report across every KWY manufacturer
- Watch product code KWY 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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