# K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Nov 25, 2008 after 60 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: 7 generations back to K810258 (1981). 27 ancestors in all.
165 later devices descend from it; 4 cite it directly.
0 of 193 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.
- K042091: Biolox Delta Ceramic Heads, Biomet, Inc. (2005) Summary page 1.
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads, Biomet, Inc. (2005) Summary page 1.
- K061312: 36MM Biolox Delta Ceramic Heads, Biomet, Inc. (2006) Summary page 1.
- K062748: Modification: to Depuy Delta Ceramic Femoral Head, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K052718: V40 Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005). Our reading of the summary gave K052781, FDA’s number for Breformance (Bredent-Products For the Dental Technician Laborat). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stryker Howmedica Osteonics V40™ Biolox delta Ceramic Femoral Head”.
- K003379: V-40/C-Taper Adapter Sleeve, Howmedica Osteonics Corp. (2000) 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

## Recalls of this device
- Aug 4, 2023 · Class II · Z-2604-2023: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, 

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; * rheumatoid arthritis; * correction of functional deformity; * femoral fracture This device may also be indicated in the salvage of previously failed surgical attempts.

Source page: https://510kreport.com/device/K082844
Methodology: https://510kreport.com/methodology