# K160289: MasterLoc Stem

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: May 20, 2016 after 107 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: 1 generation back to K151531 (2015). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K173267: MasterLoc Stem: Lateralized Plus (2017), 1 descendant of its own
- K191145: MasterLoc Extension (2019), 0 descendants of its own

## 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/K160289
Methodology: https://510kreport.com/methodology