# K021661: Ringloc Constrained Liners

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Oct 25, 2002 after 158 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: 1 generation back to P960047 (1997). 2 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960054: S-Rom Poly-Dial Constrained Liner, Depuy, A Johnson & Johnson Co. (1997) Summary page 1.
- P960047: Osteonics Constrained Acetabular Insert, Howmedica Osteonics Corp. (1997) Summary page 1.

## Most influential descendants
- K030923: Epsilon Durasul Constrained Acetabular Liner (2003), 31 descendants of its own
- K071718: Trilogy Longevity Constrained Liner (2007), 28 descendants of its own
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners (2010), 23 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own

## Indications for use
The RinglocB Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or 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/K021661
Methodology: https://510kreport.com/methodology