# K161635: AMIStem-H Proximal Coating

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 31, 2017 after 290 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: 7 generations back to K935452 (1994). 68 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S, Medacta International S.A. (2010) Summary page 4.
- K123392: Avenir Muller Stem, Zimmer GmbH (2013) Summary page 4.

## Most influential descendants
- K173794: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared (2018), 9 descendants of its own
- K181254: Quadra P (2018), 7 descendants of its own
- K192827: Quadra-P (2020), 6 descendants of its own
- K202730: Quadra-P (2020), 1 descendant of its own
- K203041: SMS Cementless Stem (2020), 1 descendant of its own

## Indications for use
The hip prosthesis AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in 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 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

Source page: https://510kreport.com/device/K161635
Methodology: https://510kreport.com/methodology