# K190890: Exactech Alteon Modular Dual Mobility (MDM) System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 22, 2019 after 200 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: 14 generations back to K810258 (1981). 140 ancestors in all.
No later device cites it as a predicate yet.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170359: Trinity™ Dual Mobility System, Corin U.S.A. Limited (2017) Summary page 4.

## Indications for use
The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation. The Alteon Acetabular System is intended for press-fit fixation.

Source page: https://510kreport.com/device/K190890
Methodology: https://510kreport.com/methodology