# K050327: E-Poly (Vitamin E) Acetabular Liners

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 27, 2005 after 230 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: 3 generations back to K810258 (1981). 13 ancestors in all.
289 later devices descend from it; 3 cite it directly.
0 of 303 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023357: Arcpm 1050 Resin-Hips, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K070364: 100KGY E-Poly Maxrom Acetabular Liners (2007), 286 descendants of its own
- K080528: E-Poly Tibial Bearings (2008), 248 descendants of its own
- K070399: 100KGY E-Poly Acetabular Liners-Additional Profiles (2007), 165 descendants of its own
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners (2007), 163 descendants of its own
- K090103: 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall (2009), 153 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

Source page: https://510kreport.com/device/K050327
Methodology: https://510kreport.com/methodology