# K050398: Exactech Ziramic Zirconia 12/14 Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Nov 18, 2005 after 275 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: 3 generations back to K993736 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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 2.

## Most influential descendants
- K060107: Modification to: Exactech Ziramic Zirconia 12/14 Femoral Heads (2006), 0 descendants of its own

## Recalls of this device
- Jun 29, 2021 · Class II · Z-2250-2021: Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

## 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. Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system. The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.

Source page: https://510kreport.com/device/K050398
Methodology: https://510kreport.com/methodology