# K200959: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Biomet UK, Ltd.
- Decided: Jul 29, 2020 after 110 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: 11 generations back to K810258 (1981). 55 ancestors in all.
No later device cites it as a predicate yet.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192683: Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads, Biomet UK, Ltd. (2020) Summary page 5.
- K182678: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling, Zimmer, Inc. (2019) Summary page 5.

## Indications for use
The Biolox® delta Ceramic Heads and 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/K200959
Methodology: https://510kreport.com/methodology