# K030047: Freedom Constrained Liners

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jan 23, 2003 after 17 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). 3 ancestors in all.
181 later devices descend from it; 4 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021728: Ringloc Constrained Liners II, Biomet, Inc. (2002)

## Most influential descendants
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), 20 descendants of its own

## Indications for use
The FreedomTMConstrained Liners are intended to replace a hip joint. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation,joint or bone loss, soft laxity, neuromuscular disease, or intra-operzhve instability and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K030047
Methodology: https://510kreport.com/methodology