# K073567: Biolox Option Ceramic Femoral Head System, Model 8777 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Mar 13, 2008 after 84 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011533 (2002). 7 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071830: Depuy Delta TS Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2007) Summary page 1.

## Most influential descendants
- K192416: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System (2019), 2 descendants of its own
- K123619: Intrablock Bioball Hip System (Ibs) (2013), 1 descendant of its own
- K223828: BENCOX Delta Option Heads (2023), 0 descendants of its own
- K201047: Fusion Taper System (2021), 0 descendants of its own
- K200112: Zimmer Hip Joint Replacement (2020), 0 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0212-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision 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/K073567
Methodology: https://510kreport.com/methodology