# K111145: Endo Head

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Aug 16, 2011 after 116 days
- Product code: LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 1.
- K062408: Smith & Nephew Modular Femoral (Hemi) Head, Smith & Nephew, Inc. (2006) Summary page 1.
- K072857: Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot, Medacta International S.A. (2008) Summary page 1.
- K080885: Medacta Total Hip Prosthesis System - Line Extension, Medacta International S.A. (2008) Summary page 1.
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 1.

## Indications for use
The Medacta Endo Head is intended for use in combination with Medacta's Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: * Femoral neck and trochanteric fractures of the proximal femur; * Osteonecrosis of the femoral head; * Revision procedures where other devices or treatments for these indications have failed.

Source page: https://510kreport.com/device/K111145
Methodology: https://510kreport.com/methodology