# K230011: Mpact Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 20, 2023 after 260 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: 13 generations back to K941847 (1994). 215 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 218 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 4.
- K132879: Mpact Extension, Medacta International (2014) Summary page 4.
- K122641: Mpact Extension, Medacta International (2012) Summary page 4.
- K183582: MPACT Extension, Medacta International S.A. (2019) Summary page 4.

## Most influential descendants
- K253630: Mpact 3D Metal Foam (2026), 0 descendants of its own
- K251043: Mpact 3D Metal Implants Extension – DMLS Technology (2026), 0 descendants of its own
- K250450: Coated hip implants (2025), 0 descendants of its own

## Indications for use
The Mpact implants are 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, post-traumatic 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/K230011
Methodology: https://510kreport.com/methodology