Freedom Constrained Liners
FDA 510(k) K030047 · Biomet, Inc.
510(k) numberK030047
Submission
- Device name
- Freedom Constrained Liners
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- January 6, 2003
- Decision date
- January 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3310
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241461 | Mpact Constrained LinerKWZ · Traditional | Medacta International S.A. | 07/31/2025SE |
| K240639 | PINNACLETM Constrained Acetabular LinersKWZ · Special | Depuy Ireland UC | 04/04/2024SE |
| K162641 | Smith & Nephew, Inc. R3 Constrained LinerKWZ · Traditional | Smith & Nephew, Inc. | 06/19/2017SE |
| K163497 | EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal…KWZ · Traditional | Encore Medical L.P. | 03/02/2017SE |
| K161610 | EXPRT Revision Hip SystemKWZ · Traditional | Encore Medical L.P. | 11/09/2016SE |
| K122139 | Smith & Nephew R3 Constrained LinersKWZ · Traditional | Smith & Nephew, Inc. | 10/16/2012SE |
| K111635 | Smith & Nephew RJ Constrained LinersKWZ · Traditional | Smith & Nephew, Inc. | 09/09/2011SE |
| K101730 | Longevity It Highly Crosslinked Polyethylene Constrained LinersKWZ · Traditional | Zimmer, Inc. | 12/03/2010SE |
| K083566 | R3 Constrained Liner, Constrained LinerKWZ · Traditional | Smith & Nephew, Inc. | 03/03/2009SE |
| K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained LinerKWZ · Traditional | Zimmer, Inc. | 01/07/2008SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | 05/19/2026SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was Freedom Constrained Liners cleared by the FDA?
Freedom Constrained Liners (K030047) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 17 days after the submission was received.
What is the product code of K030047?
The FDA product code is KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3310.