# K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jun 29, 2005 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K810258 (1981). 20 ancestors in all.
344 later devices descend from it; 6 cite it directly.
0 of 365 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042051: Arcomxl Polyethylene Liners, Biomet, Inc. (2005) Summary page 1.
- K042091: Biolox Delta Ceramic Heads, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- K071535: Biolox Delta Ceramic Femoral Head (2007), 217 descendants of its own
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve (2008), 165 descendants of its own
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners (2007), 163 descendants of its own
- K083762: Biolox Delta Ceramic Femoral Heads (2009), 149 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2145-2020: Potential presence of elevated endotoxin levels that exceed the specification limit

## 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 arthmoplasty. Intended for cemented and uncemented applications

Source page: https://510kreport.com/device/K051411
Methodology: https://510kreport.com/methodology