# K103721: Mpact Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Mar 21, 2011 after 90 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: 9 generations back to K941847 (1994). 140 ancestors in all.
21 later devices descend from it; 16 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 2.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 2.
- K091069: Medacta Bone Screws - Evolis and Versafit, Medacta International S.A. (2009) Summary page 2.
- K083116: Versafit Cup Double Mobility System, Medacta International S.A. (2009) Summary page 2.
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners, Medacta International S.A. (2010) Summary page 2.
- K101575: Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010, Omnlife Science (2010)
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK, Omni Life Science, Inc. (2010) Summary page 2.
- K080885: Medacta Total Hip Prosthesis System - Line Extension, Medacta International S.A. (2008) Summary page 2.

## Most influential descendants
- K122641: Mpact Extension (2012), 14 descendants of its own
- K132879: Mpact Extension (2014), 11 descendants of its own
- K183582: MPACT Extension (2019), 4 descendants of its own
- K230011: Mpact Extension (2023), 3 descendants of its own
- K171966: Mpact® 3D Metal™ Implants and Augments 3D Metal™ (2018), 3 descendants of its own

## Indications for use
The Mpact®E Acetabular System is intended for cementless use in total hip arthroplasty and 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 psoriactic arthritis, congenital hip dysplasia, or 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/K103721
Methodology: https://510kreport.com/methodology