# K072857: Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Feb 4, 2008 after 122 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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: 3 generations back to K932481 (1994). 5 ancestors in all.
39 later devices descend from it; 6 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001942: SL-Plus and SLR-Plus Stems, Plus Orthopedics (2000) Summary page 1.
- K021178: SL-Plus Lateralized Stem, Plus Orthopedics (2002) Summary page 1.
- K063278: Portland Cobalt Chrome Femoral Head, Portland Orthopaedics Limited (2007) Summary page 1.
- K042565: Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM Liner, Ortho Development Corp. (2005) Summary page 2.

## Most influential descendants
- K080885: Medacta Total Hip Prosthesis System - Line Extension (2008), 22 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own
- K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S (2010), 12 descendants of its own
- K132879: Mpact Extension (2014), 11 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/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/K072857
Methodology: https://510kreport.com/methodology