# K150522: G7 Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 1, 2015 after 60 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 59 ancestors in all.
21 later devices descend from it; 9 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101336: E1 Avantage Head, Biomet Manufacturing Corp (2011) Summary page 4.
- K110555: Arcomxl Active Articulation, Biomet Manufacturing Corp (2011) Summary page 4.
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 4.

## Most influential descendants
- K170359: Trinity™ Dual Mobility System (2017), 10 descendants of its own
- K161190: G7 Dual Mobility System, Active Articulation System (2016), 7 descendants of its own
- K191831: MobiliT Cup (2020), 3 descendants of its own
- K190535: BiMobile Dual Mobility System - E-Dur Inserts (2019), 3 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own

## Recalls of this device
- Feb 6, 2023 · Class II · Z-1284-2023: The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

## 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 of previously failed total hip arthroplasty. 6. Dislocation risks. The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

Source page: https://510kreport.com/device/K150522
Methodology: https://510kreport.com/methodology