# K100048: E1 Antioxidant Infused Technology

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 9, 2010 after 60 days
- Product code: OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K810258 (1981). 33 ancestors in all.
114 later devices descend from it; 5 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080528: E-Poly Tibial Bearings, Biomet Orthopedics, Inc. (2008) Summary page 1.
- K070364: 100KGY E-Poly Maxrom Acetabular Liners, Biomet, Inc. (2007) Summary page 1.
- K070399: 100KGY E-Poly Acetabular Liners-Additional Profiles, Biomet Manufacturing, Inc. (2007) Summary page 2.
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners, Biomet Manufacturing Corp (2007) Summary page 2.
- K090103: 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall, Biomet, Inc. (2009) Summary page 2.

## Most influential descendants
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (2012), 88 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K101336: E1 Avantage Head (2011), 24 descendants of its own
- K110555: Arcomxl Active Articulation (2011), 22 descendants of its own
- K150522: G7 Dual Mobility System (2015), 21 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) 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented and un-cemented use.

Source page: https://510kreport.com/device/K100048
Methodology: https://510kreport.com/methodology