# K130899: Biolox Delta Ceramic Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: May 1, 2013 after 30 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). 85 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 1.
- K123392: Avenir Muller Stem, Zimmer GmbH (2013) Summary page 1.
- K071723: Zimmer Porolock Mis Stem, Zimmer GmbH (2008) Summary page 1.

## Most influential descendants
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K210678: implaFit® hip stems (2022), 3 descendants of its own

## Indications for use
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Source page: https://510kreport.com/device/K130899
Methodology: https://510kreport.com/methodology