# K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Dec 16, 2009 after 29 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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: 8 generations back to K810258 (1981). 28 ancestors in all.
60 later devices descend from it; 3 cite it directly.
0 of 89 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.
- K090103: 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall, Biomet, Inc. (2009) Summary page 1.
- K082996: Biolox Delta Option Ceramic Heads, Biomet, Inc. (2009) Summary page 1.

## Most influential descendants
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32 (2015), 17 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own

## Indications for use
The 44mm El Tm Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M 2a Magnum T M Modular Head is for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of: 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 by other techniques. 5. Revision procedures where other treatment or devices have failed. Specific indications for compatible components that can be used with the 44mm Biolox® delta Option Ceramic Head include: Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K9 74558, K002757, K021380, K033871) Inte flocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement pmosthesis. (K990830, K042 774)

Source page: https://510kreport.com/device/K093549
Methodology: https://510kreport.com/methodology