# K131518: Mectacer Biolox Option Heads

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Nov 4, 2013 after 160 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: 10 generations back to K810258 (1981). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073337: Mectacer Biolox Forte-Femoral Heads, Medacta International S.A. (2008) Summary page 1.
- K112115: Mectacer Biolox (R) Delta Femoral Heads, Medacta International (2011) Summary page 1.
- K082996: Biolox Delta Option Ceramic Heads, Biomet, Inc. (2009) Summary page 1.
- K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum, Biomet Manufacturing Corp (2009) Summary page 1.

## Indications for use
The MectaCer BIOLOX® OPTION femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: * Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis, * Congenital hip dysplasia, * Ankytosing spondylitis, * Avascular necrosis of the femoral head, * Acute traumatic fracture of the femoral head or neck, * Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemniarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

Source page: https://510kreport.com/device/K131518
Methodology: https://510kreport.com/methodology