# K042051: Arcomxl Polyethylene Liners

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 8, 2005 after 221 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: 3 generations back to K810258 (1981). 13 ancestors in all.
355 later devices descend from it; 7 cite it directly.
0 of 369 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
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- 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

## Recalls of this device
- Feb 17, 2017 · Class II · Z-1860-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## 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 arthropiasty. Cemented and Uncemented Applications

Source page: https://510kreport.com/device/K042051
Methodology: https://510kreport.com/methodology