# K062997: Arcomxl  Polyethylene Liners and 38/40MM Femoral  Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Dec 8, 2006 after 67 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881288 (1988). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 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.
- 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.
- K011110: M2A Acetabular System, Biomet, Inc. (2001)
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 1.

## Recalls of this device
- Feb 7, 2012 · Not classified · Z-1143-2012: Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.
- Sep 13, 2011 · Not classified · Z-1449-2012: Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.

## 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 arthroplasty. Cemented and Uncemented Applications

Source page: https://510kreport.com/device/K062997
Methodology: https://510kreport.com/methodology