# K103012: Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox Option Adapters/Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Nov 10, 2010 after 29 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: 4 generations back to K993736 (2000). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032964: Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments, Exactech, Inc. (2003) Summary page 1.
- K051682: Exactech 12/14 Alumina Femoral Heads 36 MM, Exactech, Inc. (2005) Summary page 1.

## Most influential descendants
- K121392: Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree (2013), 4 descendants of its own
- K173583: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (2018), 3 descendants of its own
- K182502: Alteon Acetabular Cup System (2019), 2 descendants of its own
- K210614: BENCOX Mirabo Z Cup Cortinium (2022), 1 descendant of its own
- K223223: BENCOX Mirabo Z Cup Cortinium (2023), 0 descendants of its own

## Indications for use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. * Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. * Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon * Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K103012
Methodology: https://510kreport.com/methodology