# K111635: Smith & Nephew RJ Constrained Liners

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 9, 2011 after 88 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: 2 generations back to P960047 (1997). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083566: R3 Constrained Liner, Constrained Liner, Smith & Nephew, Inc. (2009) Summary page 1.
- (no number) Reflection Constrained Liners: named in the summary without a submission number

## Most influential descendants
- K241461: Mpact Constrained Liner (2025), 1 descendant of its own
- K122139: Smith & Nephew R3 Constrained Liners (2012), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K162641: Smith & Nephew, Inc. R3™ Constrained Liner (2017), 0 descendants of its own

## Indications for use
The R3 Constrained Liner Acetabular System is a cemented or 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 intra-operative 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/K111635
Methodology: https://510kreport.com/methodology