# K220405: Amis K Long

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 12, 2022 after 57 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: 11 generations back to K935452 (1994). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192827: Quadra-P, Medacta International S.A. (2020) Summary page 4.
- K201471: M-Vizion Femoral Revision System Extension, Medacta International S.A. (2021) Summary page 4.
- K083558: Medacta Total Hip Prosthesis System - Quadra C, Medacta International S.A. (2009) Summary page 4.
- K100469: Arcos Interlocking Distal Stems, Biomet Manufacturing Corp (2010) Summary page 4.

## Indications for use
The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Total 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. Partial hip arthroplasty is indicated in the following cases: • Acute traumatic fracture of the femoral head or neck • Non-union of femoral neck fracture • Avascular necrosis of the femoral head. • Primary pathology involving the femoral head but with a non-deformed acetabulum.

Source page: https://510kreport.com/device/K220405
Methodology: https://510kreport.com/methodology