# K162641: Smith & Nephew, Inc. R3™ Constrained Liner

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 19, 2017 after 270 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K861766 (1986). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111635: Smith & Nephew RJ Constrained Liners, Smith & Nephew, Inc. (2011) Summary page 4.
- K122139: Smith & Nephew R3 Constrained Liners, Smith & Nephew, Inc. (2012) Summary page 4.
- K021803: Reflection Constrained Liner, Smith & Nephew, Inc. (2002) Summary page 4.
- K033442: Reflection Constrained Liner, Smith & Nephew, Inc. (2003) Summary page 4.
- K113848: R3 Xlpe Liners, Smith & Nephew, Inc. (2012) Summary page 4.
- K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads, DePuy Orthopaedics, Inc. (2004) Summary page 4.

## Indications for use
The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Source page: https://510kreport.com/device/K162641
Methodology: https://510kreport.com/methodology