# K122641: Mpact Extension

- Pathway: 510(k) (Special)
- Applicant: Medacta International
- Decided: Sep 28, 2012 after 30 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: 10 generations back to K941847 (1994). 141 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 1.
- K033338: Pinnacle Revision System, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K132879: Mpact Extension (2014), 11 descendants of its own
- K183582: MPACT Extension (2019), 4 descendants of its own
- K230011: Mpact Extension (2023), 3 descendants of its own
- K171966: Mpact® 3D Metal™ Implants and Augments 3D Metal™ (2018), 3 descendants of its own
- K131458: Mpact DM Liner Converter (2013), 3 descendants of its own

## Indications for use
The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: * Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. * Avascular necrosis of the femoral head. * Acute traumatic fracture of the femoral head or neck. * Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty; surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

Source page: https://510kreport.com/device/K122641
Methodology: https://510kreport.com/methodology