# K131684: Biolox (R) Delta Ceramic Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 10, 2013 after 122 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: 7 generations back to K810258 (1981). 25 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042091: Biolox Delta Ceramic Heads, Biomet, Inc. (2005) Summary page 2.
- K061312: 36MM Biolox Delta Ceramic Heads, Biomet, Inc. (2006) Summary page 2.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 2.

## Most influential descendants
- K141653: Biolox Delta Ceramic Option Heads (2014), 4 descendants of its own
- K192683: Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads (2020), 2 descendants of its own
- K181171: Zimmer Biomet Ceramic Heads (2019), 2 descendants of its own
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own

## Recalls of this device
- Jun 30, 2017 · Class II · Z-0992-2018: Product may contain the presence of melted sterile packaging upon opening.
- Jun 30, 2017 · Class II · Z-0993-2018: For soft tissue fixation

## Indications for use
Biolox® delta 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, K021 380, K033871 )* Interlocking hip stems are indicated for nan-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)* *Note - for the USA only

Source page: https://510kreport.com/device/K131684
Methodology: https://510kreport.com/methodology