# K171966: Mpact® 3D Metal™ Implants and Augments 3D Metal™

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 27, 2018 after 270 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). 157 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 160 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.
- K122641: Mpact Extension, Medacta International (2012) Summary page 4.
- K132879: Mpact Extension, Medacta International (2014) Summary page 4.
- K100391: Depuy Universal Gription TF Cones, DePuy Orthopaedics, Inc. (2010) Summary page 4.

## Most influential descendants
- K202568: Mpact® 3D Metal Implants - DMLS Technology (2021), 1 descendant of its own
- K251043: Mpact 3D Metal Implants Extension – DMLS Technology (2026), 0 descendants of its own
- K242232: Mpact 3D Metal Augments II (2025), 0 descendants of its own

## Indications for use
Mpact 3D Metal Implants The Mpact 3D Metal Implants is designed to be used in total hip arthroplasty, for primary or revision surgery. The patient should be skeletally mature. Total hip arthroplasty is indicated in the following cases: • Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic 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. Augments 3D Metal 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.

Source page: https://510kreport.com/device/K171966
Methodology: https://510kreport.com/methodology