# K101336: E1 Avantage Head

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jan 14, 2011 after 247 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 39 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 1.
- K093644: Restoration Adm System X3 Acetabular, Howmedica Osteonics Corp. (2009) Summary page 1.
- K991990: Tri-Polar System, Biomet, Inc. (1999) Summary page 1.
- K070364: 100KGY E-Poly Maxrom Acetabular Liners, Biomet, Inc. (2007) Summary page 2.
- K070399: 100KGY E-Poly Acetabular Liners-Additional Profiles, Biomet Manufacturing, Inc. (2007) Summary page 1.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 1.
- K083116: Versafit Cup Double Mobility System, Medacta International S.A. (2009) Summary page 1.
- K050327: E-Poly (Vitamin E) Acetabular Liners, Biomet, Inc. (2005) Summary page 1.
- K100048: E1 Antioxidant Infused Technology, Biomet Manufacturing Corp (2010) Summary page 1.

## Most influential descendants
- K110555: Arcomxl Active Articulation (2011), 22 descendants of its own
- K150522: G7 Dual Mobility System (2015), 21 descendants of its own
- K170359: Trinity™ Dual Mobility System (2017), 10 descendants of its own
- K161190: G7 Dual Mobility System, Active Articulation System (2016), 7 descendants of its own
- K191831: MobiliT Cup (2020), 3 descendants of its own

## Recalls of this device
- Apr 26, 2013 · Class II · Z-1465-2013: Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes whil

## Indications for use
1. Noninflammatory 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. 6. Dislocation risks. The El™ Avantage™ Head is a single-use implant, intended for uncemented applications.

Source page: https://510kreport.com/device/K101336
Methodology: https://510kreport.com/methodology