# K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 10, 2015 after 131 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 76 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121874: G7 Acetabular System, Biomet Manufacturing Corp (2012) Summary page 5.
- K030047: Freedom Constrained Liners, Biomet, Inc. (2003) Summary page 5.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 5.
- K870271: S-Rom Poly-Dial Constrained Socket for Acet. Cup, Joint Medical Products Corp. (1987) Summary page 5.

## Most influential descendants
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own
- K190660: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene (2019), 4 descendants of its own
- K190535: BiMobile Dual Mobility System - E-Dur Inserts (2019), 3 descendants of its own
- K241636: MobileLink Acetabular Cup System - Line Extension (Multiple) (2024), 2 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use. Additional indications for Biomet G7 Freedom Constrained Liners: The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K142882
Methodology: https://510kreport.com/methodology