# K061312: 36MM Biolox Delta Ceramic Heads

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jun 6, 2006 after 27 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: 5 generations back to K810258 (1981). 21 ancestors in all.
343 later devices descend from it; 7 cite it directly.
0 of 365 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 1.
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K071535: Biolox Delta Ceramic Femoral Head (2007), 217 descendants of its own
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve (2008), 165 descendants of its own
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners (2007), 163 descendants of its own
- K083762: Biolox Delta Ceramic Femoral Heads (2009), 149 descendants of its own
- K100412: Biolox Delta Ceramic Femoral Heads (2010), 140 descendants of its own

## Indications for use
BioloxV 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 osteoarthuitis 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 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/K061312
Methodology: https://510kreport.com/methodology