# K083566: R3 Constrained Liner, Constrained Liner

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 3, 2009 after 90 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P960047 (1997). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960047: Osteonics Constrained Acetabular Insert, Howmedica Osteonics Corp. (1997) Summary page 1.

## Most influential descendants
- K111635: Smith & Nephew RJ Constrained Liners (2011), 4 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- 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

## Recalls of this device
- May 6, 2015 · Class II · Z-1739-2015: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
- May 6, 2015 · Class II · Z-1735-2015: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
- May 6, 2015 · Class II · Z-1738-2015: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
- May 6, 2015 · Class II · Z-1736-2015: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
- May 6, 2015 · Class II · Z-1737-2015: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
- Aug 13, 2010 · Not classified · Z-0081-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0085-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0080-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0082-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0086-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0079-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0083-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.
- Aug 13, 2010 · Not classified · Z-0084-2011: The firm received reports of a femoral head popping out of the liner intraoperatively.

## 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/K083566
Methodology: https://510kreport.com/methodology