# K141653: Biolox Delta Ceramic Option Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 18, 2014 after 59 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: 9 generations back to K810258 (1981). 33 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082996: Biolox Delta Option Ceramic Heads, Biomet, Inc. (2009) Summary page 5.
- K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum, Biomet Manufacturing Corp (2009) Summary page 5.
- K131684: Biolox (R) Delta Ceramic Heads, Biomet, Inc. (2013) Summary page 5.

## Most influential descendants
- K192683: Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads (2020), 2 descendants of its own
- K243809: Biolox® Delta Revision heads (2025), 0 descendants of its own
- K200959: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling (2020), 0 descendants of its own
- K181761: Zimmer Biomet Select Ceramic Heads (2018), 0 descendants of its own

## Indications for use
Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of: 1. Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis. 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 procedures where other treatment or devices have failed. Specific indications for compatible components that can be used with the above modular heads include: Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871) Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

Source page: https://510kreport.com/device/K141653
Methodology: https://510kreport.com/methodology