# K191145: MasterLoc Extension

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: May 30, 2019 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K151531 (2015). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151531: MasterLoc Stem, Medacta International (2015) Summary page 4.
- K160289: MasterLoc Stem, Medacta International (2016) Summary page 4.
- K173267: MasterLoc Stem: Lateralized Plus, Medacta International S.A. (2017) Summary page 4.

## Indications for use
The hip prosthesis MasterLoc" is designed for cementless 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/K191145
Methodology: https://510kreport.com/methodology