# K070364: 100KGY E-Poly Maxrom Acetabular Liners

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 3, 2007 after 85 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K810258 (1981). 14 ancestors in all.
286 later devices descend from it; 5 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050327: E-Poly (Vitamin E) Acetabular Liners, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K080528: E-Poly Tibial Bearings (2008), 248 descendants of its own
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners (2007), 163 descendants of its own
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 (2010), 119 descendants of its own
- 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

## Indications for use
1) Non-inflammatory degenerative joint disease including osteaarthritis 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

Source page: https://510kreport.com/device/K070364
Methodology: https://510kreport.com/methodology