# K151531: MasterLoc Stem

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Oct 30, 2015 after 144 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
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K046474: Medacta Total Hip Prosthesis. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K170845: MiniMAX (2017), 7 descendants of its own
- K181693: SMS Femoral Stem (2018), 4 descendants of its own
- K201673: SMS Cementless Stem (2020), 3 descendants of its own
- K192352: MiniMAX (2019), 2 descendants of its own
- K160289: MasterLoc Stem (2016), 2 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/K151531
Methodology: https://510kreport.com/methodology