# K121011: Amistem and Quadra - Line Extension

- Pathway: 510(k) (Special)
- Applicant: Medacta International
- Decided: Jun 8, 2012 after 66 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: 5 generations back to K932481 (1994). 8 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072857: Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot, Medacta International S.A. (2008) Summary page 1.
- K082792: Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems, Medacta International S.A. (2008) Summary page 1.
- K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S, Medacta International S.A. (2010) Summary page 1.

## 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 Medacta Total Hip Prosthesis System is intended for-cementless 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Source page: https://510kreport.com/device/K121011
Methodology: https://510kreport.com/methodology