# K193433: AMIStem-C

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Jan 9, 2020 after 30 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932481 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103189: Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short Neck, Medacta International S.A. (2010) Summary page 4.

## Indications for use
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement 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 » Acute traumatic fracture of the femoral head or neck » Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

Source page: https://510kreport.com/device/K193433
Methodology: https://510kreport.com/methodology