510(k) · Cleared
ClearedMasterLoc Stem: Lateralized Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 7, 2017 as substantially equivalent to K151531 (Medacta International, 2015) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 2015. 1 later device descends from it.
- Decided
- Dec 7, 2017
- Review
- 57 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K151531 (2015). 3 ancestors in all, the oldest K052792 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK151531 MasterLoc StemMedacta International · 2015
- 1 generation backK160289 MasterLoc StemMedacta International · 2016
- This deviceK173267 MasterLoc Stem: Lateralized PlusMedacta International S.A. · 2017
- Descendant · cites it directly · 0 of its ownK191145 MasterLoc ExtensionMedacta International S.A. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191145MasterLoc ExtensionMedacta International S.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K151531 | MasterLoc Stem | Medacta International | 2015 | — |
| −1 | K160289 | MasterLoc Stem | Medacta International | 2016 | — |
| 0 (this device) | K173267 | MasterLoc Stem: Lateralized Plus | Medacta International S.A. | 2017 | — |
| +1 | K191145 | MasterLoc Extension | Medacta International S.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151531 | MasterLoc StemSummary page 4…88.3360 Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: MasterLoc™ Stem, K151531, Medacta International SA MasterLoc™ Stem, K160289, Medacta International SA Additional Predicates: Anthology Hip Stem… | 2015 |
| * | K160289 | MasterLoc StemSummary page 4…ate Device Substantial equivalence is claimed to the following devices: Primary Predicate: MasterLoc™ Stem, K151531, Medacta International SA MasterLoc™ Stem, K160289, Medacta International SA Additional Predicates: Anthology Hip Stem, K052792, Smith & Nephew, Inc. IV. Device Descript… | 2016 |
| * | K052792 | Anthology Hip StemSummary page 4…edicate: MasterLoc™ Stem, K151531, Medacta International SA MasterLoc™ Stem, K160289, Medacta International SA Additional Predicates: Anthology Hip Stem, K052792, Smith & Nephew, Inc. IV. Device Description The MasterLoc™ Stem: Lateralized Plus implants are a line extension to Medacta… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191145 | MasterLoc Extension | 2019 | 0 |
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K191145 (Medacta International S.A., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K151531.
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. 2017, 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 as stated in the FDA summary.
https://510kreport.com/device/K173267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173267: MasterLoc Stem: Lateralized Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173267
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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