# K023794: Constrained Liner

- Pathway: 510(k) (Abbreviated)
- Applicant: Encore Medical L.P.
- Decided: Apr 1, 2003 after 139 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 P960054 (1997). 3 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950202: Ringloc Constrained Liner, Biomet, Inc. (1995) Summary page 2.
- P960054: S-Rom Poly-Dial Constrained Liner, Depuy, A Johnson & Johnson Co. (1997) Summary page 2.
- K021826: Trilogy Acetabular System Constrained Liner, Model 6154 Series, Zimmer, Inc. (2002). Cleared while this submission was under review

## Most influential descendants
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K152903: REVIVAL (TM) Modular Revision Hip Stem (2016), 4 descendants of its own
- K140975: Mastersl Femoral Stem (2014), 4 descendants of its own
- K191374: Revival Modular Hip Stem (2019), 3 descendants of its own

## Indications for use
The FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of 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.

Source page: https://510kreport.com/device/K023794
Methodology: https://510kreport.com/methodology