# K083762: Biolox Delta Ceramic Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 11, 2009 after 83 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: 7 generations back to K810258 (1981). 34 ancestors in all.
149 later devices descend from it; 9 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981847: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (1998) Summary page 1.
- K991162: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (2000) Summary page 1.
- K022958: Total Hip Femoral Heads and Liners, Smith & Nephew, Inc. (2002) Summary page 1.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 1.

## Most influential descendants
- K100412: Biolox Delta Ceramic Femoral Heads (2010), 140 descendants of its own
- K103120: Corin Biolox Delta Femoral Heads (2011), 110 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K111911: Corin Optimom Modular Head (2011), 62 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own

## Indications for use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques;. femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Biolox Delta Ceramic femoral heads are for single. use only.

Source page: https://510kreport.com/device/K083762
Methodology: https://510kreport.com/methodology