# K052255: Arcomxl Polyethylene RX90 Acetabular Liners

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Nov 23, 2005 after 97 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854046 (1985). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042989: RX90 Low Profile Acetabular System, Biomet, Inc. (2005) Summary page 1.

## Indications for use
The ArComXL TM Polyethylene Rx9O TM Low Profile Acetabular Liners are indicated for cemented or non-cemented use 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 of previously failed total hip arthroplasty.

Source page: https://510kreport.com/device/K052255
Methodology: https://510kreport.com/methodology