R3 Constrained Liner, Constrained Liner
FDA 510(k) K083566 · Smith & Nephew, Inc.
510(k) numberK083566
Submission
- Device name
- R3 Constrained Liner, Constrained Liner
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- December 3, 2008
- Decision date
- March 3, 2009
- 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 |
| 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 |
| 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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| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was R3 Constrained Liner, Constrained Liner cleared by the FDA?
R3 Constrained Liner, Constrained Liner (K083566) received a 510(k) decision of Substantially Equivalent on March 3, 2009, 90 days after the submission was received.
What is the product code of K083566?
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.