# K103189: Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short Neck

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Dec 20, 2010 after 53 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932481 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083558: Medacta Total Hip Prosthesis System - Quadra C, Medacta International S.A. (2009) Summary page 1.

## Most influential descendants
- K193433: AMIStem-C (2020), 0 descendants of its own

## Recalls of this device
- Dec 17, 2012 · Class II · Z-0791-2013: The tip of the Quadra Trial Broach size 0, broke during a surgery.

## Indications for use
The Medacta Total Hip Prosthesis System - Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery. Hip replacement is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia * 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, hemniarthroplasty, surface replacement arthroplasty, or total hip replacement. Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

Source page: https://510kreport.com/device/K103189
Methodology: https://510kreport.com/methodology