# K071535: Biolox Delta Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 19, 2007 after 167 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810258 (1981). 24 ancestors in all.
217 later devices descend from it; 15 cite it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061312: 36MM Biolox Delta Ceramic Heads, Biomet, Inc. (2006)
- K062748: Modification: to Depuy Delta Ceramic Femoral Head, DePuy Orthopaedics, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K052718: V40 Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve (2008), 165 descendants of its own
- K083762: Biolox Delta Ceramic Femoral Heads (2009), 149 descendants of its own
- 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

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0336-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Dec 17, 2014 · Class II · Z-1134-2015: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is con
- Sep 4, 2012 · Class II · Z-0211-2013: 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 defta 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, osteparthritis, 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 acetabul, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with peeviously failed endoprostheses and/or total hip components in the operative extremity; and patients with agute neck fractures,

Source page: https://510kreport.com/device/K071535
Methodology: https://510kreport.com/methodology