# K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Jan 21, 2010 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932481 (1994). 6 ancestors in all.
12 later devices descend from it; 4 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.

## Most influential descendants
- K161635: AMIStem-H Proximal Coating (2017), 10 descendants of its own
- K121011: Amistem and Quadra - Line Extension (2012), 10 descendants of its own
- 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

## 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 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/ar 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 arthmoplasty, or total hip replacement.

Source page: https://510kreport.com/device/K093944
Methodology: https://510kreport.com/methodology