# K042091: Biolox Delta Ceramic Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 25, 2005 after 234 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: 2 generations back to K011533 (2002). 5 ancestors in all.
345 later devices descend from it; 7 cite it directly.
0 of 351 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943586: Zirconia Ceramic Modular Heads (Astro Met), Biomet, Inc. (1994) Summary page 1.
- K925345: Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM), Biomet, Inc. (1994) Summary page 1.
- K905687: Zirconia Ceramic Modular Heads, Biomet, Inc. (1991) Summary page 1.
- K031803: Depuy Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- 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

## Recalls of this device
- Mar 16, 2009 · Not classified · Z-1614-2009: The firm has received reports of fractured heads, requiring revision surgery.
- Mar 16, 2009 · Not classified · Z-1613-2009: The firm has received reports of fractured heads, requiring revision surgery.

## 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 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. 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.

Source page: https://510kreport.com/device/K042091
Methodology: https://510kreport.com/methodology