# K200391: MPACT Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 28, 2021 after 435 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: 12 generations back to K941847 (1994). 143 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 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 5.
- K132879: Mpact Extension, Medacta International (2014) Summary page 5.

## 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. The Mpact 3D Metal 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. The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries. The Augments 3D Metal are indicated in cases of: * Congenital dysplasia. * Acetabular fractures. * Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures. The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole 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/K200391
Methodology: https://510kreport.com/methodology