510(k) · Cleared
ClearedMasterLoc Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 30, 2015 after a 144-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 11 later devices descend from it.
- Decided
- Oct 30, 2015
- Review
- 144 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
11 later devices descend from it, 4 citing it directly.
- This deviceK151531 MasterLoc StemMedacta International · 2015
- Descendant · cites it directly · 7 of its ownK170845 MiniMAXMedacta International S.A. · 2017 · Recalled
- Descendant · 2 generations on · 4 of its ownK181693 SMS Femoral StemMedacta International S.A. · 2018
- Descendant · 3 generations on · 3 of its ownK201673 SMS Cementless StemMedacta International S.A. · 2020
- Descendant · 2 generations on · 2 of its ownK192352 MiniMAXMedacta International S.A. · 2019
- Descendant · cites it directly · 2 of its ownK160289 MasterLoc StemMedacta International · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170845MiniMAXMedacta International S.A. · 2017 · cites it directly7descendants
- K181693SMS Femoral StemMedacta International S.A. · 2018 · 2 generations on4descendants
- K201673SMS Cementless StemMedacta International S.A. · 2020 · 3 generations on3descendants
- K192352MiniMAXMedacta International S.A. · 2019 · 2 generations on2descendants
- K160289MasterLoc StemMedacta International · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151531 | MasterLoc Stem | Medacta International | 2015 | — |
| +1 | K170845 | MiniMAX | Medacta International S.A. | 2017 | 1 |
| +2 | K181693 | SMS Femoral Stem | Medacta International S.A. | 2018 | — |
| +3 | K201673 | SMS Cementless Stem | Medacta International S.A. | 2020 | — |
| +2 | K192352 | MiniMAX | Medacta International S.A. | 2019 | — |
| +1 | K160289 | MasterLoc Stem | Medacta International | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K090317 | FDA’s K090317 is Babi*Plus Bubble Pap Valve Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| 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 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170845 (Medacta International S.A., 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151531: MasterLoc Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151531
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026