# K162732: Exactech® Alteon® HA Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Apr 26, 2017 after 209 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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 K931641 (1994). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153649: Exactech® Novation® Element Press-fit Femoral Stem, Exactech, Inc. (2016) Summary page 4.

## Most influential descendants
- K243839: Alteon® HA Femoral Stems (2025), 0 descendants of its own

## Recalls of this device
- Oct 9, 2017 · Class II · Z-0538-2018: Wrong device description of the label identifying the implant

## 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 Alteon HA femoral stems are intended for press-fit fixation.

Source page: https://510kreport.com/device/K162732
Methodology: https://510kreport.com/methodology