# K253630: Mpact 3D Metal Foam

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Aug 28, 2026 after 282 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: 14 generations back to K941847 (1994). 223 ancestors in all.
No later device cites it as a predicate yet.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050937: Trabecular Metal Acetabular Revision Shells, Zimmer Trabecular (2005) Summary page 5.
- K061226: Trabecular Metal Acetabular Revision System Cage, Zimmer, Inc. (2006) Summary page 5.
- K051516: Trabecular Metal Revision Shell Liners, Zimmer, Inc. (2005) Summary page 5.
- K150790: REDAPT Porous Acetabular Shell and Cemented Liner, Smith & Nephew, Inc. (2015) Summary page 5.
- K230011: Mpact Extension, Medacta International S.A. (2023) Summary page 5.
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 5.
- K122641: Mpact Extension, Medacta International (2012) Summary page 5.

## Indications for use
Mpact 3D Metal Foam is intended to be used in cementless hip replacement surgeries in combination with Medacta F-Cage and a Medacta cemented cup (Apricot or Versacem), or in combination with a Medacta cemented cup only. Mpact 3D Metal Foam, Medacta F-Cage and Apricot are indicated for use in the case of acetabular bony defect during total hip arthroplasty. Total hip arthroplasty is indicated in the following cases: » Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. * Avascular necrosis of the femoral head when total hip arthroplasty has been chosen. * Acute traumatic fracture of the femoral head or neck when total hip arthroplasty has been chosen. » Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty. When the Mpact 3D Metal Foam is used with the Versacem, is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases: * Elderly patients or poor bone quality. * Revision for recurrent dislocation in elderly patients with poor bone quality. » Patients treated with radiotherapy or chemotherapy. Versacem is intended for cemented use only.

Source page: https://510kreport.com/device/K253630
Methodology: https://510kreport.com/methodology