Smith & Nephew, Inc. R3 Constrained Liner
FDA 510(k) K162641 · Smith & Nephew, Inc.
510(k) numberK162641
Submission
- Device name
- Smith & Nephew, Inc. R3 Constrained Liner
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- September 22, 2016
- Decision date
- June 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K071059 | Depuy SPA Porous Coated Proximal SleeveKWZ · Traditional | DePuy Orthopaedics, Inc. | 11/09/2007SE |
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
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Questions and answers
When was Smith & Nephew, Inc. R3 Constrained Liner cleared by the FDA?
Smith & Nephew, Inc. R3 Constrained Liner (K162641) received a 510(k) decision of Substantially Equivalent on June 19, 2017, 270 days after the submission was received.
What is the product code of K162641?
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.