# K242232: Mpact 3D Metal Augments II

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 23, 2025 after 267 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). 158 ancestors in all.
No later device cites it as a predicate yet.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171966: Mpact® 3D Metal™ Implants and Augments 3D Metal™, Medacta International S.A. (2018) Summary page 5.

## Indications for use
Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries. Mpact 3D Metal Augments are indicated in cases of: • Acetabular dysplasia; • Acetabular fractures; • Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

Source page: https://510kreport.com/device/K242232
Methodology: https://510kreport.com/methodology