# K161190: G7 Dual Mobility System, Active Articulation System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 26, 2016 after 29 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: 11 generations back to K810258 (1981). 60 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 4.
- K101336: E1 Avantage Head, Biomet Manufacturing Corp (2011) Summary page 4.
- K110555: Arcomxl Active Articulation, Biomet Manufacturing Corp (2011) Summary page 4.

## Most influential descendants
- K200011: E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (2021), 1 descendant of its own
- K190656: Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings (2019), 1 descendant of its own
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (2024), 0 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 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/K161190
Methodology: https://510kreport.com/methodology