# K150066: Exactech Alteon Monobloc Revision Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jul 20, 2015 after 188 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: 2 generations back to K953689 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043356: Wagner SL Revision Stem Lateral, Zimmer Austin, Inc. (2005) Summary page 4.

## Most influential descendants
- K181532: Exactech Alteon Monobloc Revision Stem (2018), 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. • Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K150066
Methodology: https://510kreport.com/methodology