# K090103: 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 11, 2009 after 27 days
- Product code: MAY (Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K810258 (1981). 15 ancestors in all.
153 later devices descend from it; 2 cite it directly.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070399: 100KGY E-Poly Acetabular Liners-Additional Profiles, Biomet Manufacturing, Inc. (2007) Summary page 1.

## Most influential descendants
- K100048: E1 Antioxidant Infused Technology (2010), 114 descendants of its own
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (2012), 88 descendants of its own
- K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum (2009), 60 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K121874: G7 Acetabular System (2012), 53 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 using other techniques. 5. Revision of previously, failed total hip arthroplasty. Cemented and Uncemented Applications (as based on mating shell)

Source page: https://510kreport.com/device/K090103
Methodology: https://510kreport.com/methodology