FDA product code KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KWZ is the FDA product code for prosthesis, hip, constrained, cemented or uncemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3310 and reviewed by the Orthopedic panel. FDA has cleared 34 510(k) submissions under KWZ, 2 in the last five years, from 15 different applicants. The average 510(k) review took 121 days (median 104); 232 days on average over the last three years. 2 PMA applications cite this product code. FDA has posted 20 recalls for KWZ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3310 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 174 |
| 2024 | 1 | 29 |
| 2025 | 1 | 434 |
Compare with all 510(k) review times · Search every KWZ clearance
Top KWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 6 | 2017-06-19 |
| Zimmer, Inc. | 4 | 2010-12-03 |
| Howmedica Osteonics Corp. | 4 | 2007-03-08 |
| Encore Medical L.P. | 3 | 2017-03-02 |
| DePuy Orthopaedics, Inc. | 3 | 2007-11-09 |
10 more applicants have KWZ clearances. See the full list in Caduvo.
Most recent KWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241461 | Medacta International S.A. | Mpact Constrained Liner | 2025-07-31 | 434 |
| K240639 | Depuy Ireland UC | PINNACLETM Constrained Acetabular Liners | 2024-04-04 | 29 |
| K162641 | Smith & Nephew, Inc. | Smith & Nephew, Inc. R3 Constrained Liner | 2017-06-19 | 270 |
| K163497 | Encore Medical L.P. | EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt | 2017-03-02 | 79 |
| K161610 | Encore Medical L.P. | EXPRT Revision Hip System | 2016-11-09 | 152 |
Recalls for KWZ devices
20 product recalls in 8 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KWZ?
KWZ is the FDA product code for prosthesis, hip, constrained, cemented or uncemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3310 and reviewed by the Orthopedic panel.
What device class is KWZ?
Class II, regulation 21 CFR 888.3310. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWZ?
Across 34 cleared submissions the average was 121 days from receipt to decision (median 104).
Which companies have the most KWZ clearances?
Smith & Nephew, Inc. (6); Zimmer, Inc. (4); Howmedica Osteonics Corp. (4); Encore Medical L.P. (3); DePuy Orthopaedics, Inc. (3).
Have KWZ devices been recalled?
Yes: 20 product recalls across 8 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KWZ
- Run a recall and safety report across every KWZ manufacturer
- Watch product code KWZ 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times