# K082991: Biolox Delta Ceramic Femoral Head

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Nov 20, 2008 after 44 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: 8 generations back to K941847 (1994). 100 ancestors in all.
63 later devices descend from it; 4 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 1.
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head, Aesculap, Inc. (2006) Summary page 1.
- K062684: Excia Total Hip System 36MM Ceramic Head, Aesculap, Inc. (2006) Summary page 1.
- K080584: Metha Short Stem Hip System, Aesculap Implant System, Inc. (2008) Summary page 1.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 1.

## Most influential descendants
- K083495: Modification to: Metha Hip System (2009), 59 descendants of its own
- K090845: Apex Arc Hip Stem (2010), 58 descendants of its own
- K111193: Apex Arc Hip Stem (2011), 53 descendants of its own
- K113242: Apex Arc Hip Stem (2012), 52 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own

## Indications for use
The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip 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, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without p-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement 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, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures

Source page: https://510kreport.com/device/K082991
Methodology: https://510kreport.com/methodology