# K082996: Biolox Delta Option Ceramic Heads

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jan 15, 2009 after 99 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: 4 (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). 26 ancestors in all.
61 later devices descend from it; 3 cite it directly.
0 of 88 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.
- K061312: 36MM Biolox Delta Ceramic Heads, Biomet, Inc. (2006) Summary page 1.
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners, Biomet Manufacturing Corp (2007) Summary page 1.

## Most influential descendants
- K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum (2009), 60 descendants of its own
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32 (2015), 17 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-3132-2024: Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the slee
- Aug 8, 2024 · Class II · Z-3133-2024: Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the slee
- Jun 5, 2017 · Class II · Z-0302-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Jun 5, 2017 · Class II · Z-0301-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

## 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/K082996
Methodology: https://510kreport.com/methodology