# K132879: Mpact Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jan 22, 2014 after 131 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K941847 (1994). 142 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 153 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.
- K122641: Mpact Extension, Medacta International (2012) Summary page 1.
- K033338: Pinnacle Revision System, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K202568: Mpact® 3D Metal Implants - DMLS Technology (2021), 1 descendant of its own
- K143453: Mpact Double Mobility System (2015), 1 descendant 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 patients condition should be due to one or more at: 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, hemniarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bope stock is present.

Source page: https://510kreport.com/device/K132879
Methodology: https://510kreport.com/methodology