510(k) Report

510(k) · Cleared

Cleared

MasterLoc Extension

K191145510(k) SpecialCleared May 30, 201930-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on May 30, 2019 as substantially equivalent to K151531 (Medacta International, 2015) and 2 other predicates after a 30-day review. Its family tree reaches back 3 generations to 2015.

Decided
May 30, 2019
Review
30 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K151531 (2015). 4 ancestors in all, the oldest K052792 (2005). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestorK151531 · MasterLoc Stem · Medacta International · 2015K160289 · MasterLoc Stem · Medacta International · 2016K173267 · MasterLoc Stem: Lateralized Plus · Medacta International S.A. · 20172005201020152020
Other ancestors, by generation 2 generations back: 1 other ancestor K173267 · MasterLoc Stem: Lateralized Plus · Medacta International S.A. · 2017K160289 · MasterLoc Stem · Medacta International · 2016K151531 · MasterLoc Stem · Medacta International · 20150
  1. Root · 3 generations backK151531 MasterLoc StemMedacta International · 2015
  2. 2 generations backK160289 MasterLoc StemMedacta International · 2016
  3. 1 generation backK173267 MasterLoc Stem: Lateralized PlusMedacta International S.A. · 2017
  4. This deviceK191145 MasterLoc ExtensionMedacta International S.A. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K151531MasterLoc StemMedacta International2015—
−2K160289MasterLoc StemMedacta International2016—
−1K173267MasterLoc Stem: Lateralized PlusMedacta International S.A.2017—
0 (this device)K191145MasterLoc ExtensionMedacta International S.A.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K191145, 2015–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K151531MasterLoc Stem
Summary page 4
…8, 21 CFR 888.3360 Device Classification 11 111. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: e MasterLoc™" Stem, K151531, Medacta International SA Additional Predicates: e MasterLoc™ Stem, K160289, Medacta International SA MasterLoc™ Stem: Lateraliz…
Medacta International2015—
*K160289MasterLoc Stem
Summary page 4
…ial equivalence is claimed to the following devices: Primary Predicate: e MasterLoc™" Stem, K151531, Medacta International SA Additional Predicates: e MasterLoc™ Stem, K160289, Medacta International SA MasterLoc™ Stem: Lateralized Plus K173267, Medacta International SA ™ ) K191145 Page 2/…
Medacta International2016—
*K173267MasterLoc Stem: Lateralized Plus
Summary page 4
…ate: e MasterLoc™" Stem, K151531, Medacta International SA Additional Predicates: e MasterLoc™ Stem, K160289, Medacta International SA MasterLoc™ Stem: Lateralized Plus K173267, Medacta International SA ™ ) K191145 Page 2/4 MasterLoc'™ Stem Extension Special 510(k) Medacta International S…
Medacta International S.A.2017—

Also cleared against K151531: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K151531.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

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.

Also cleared against K151531

3 other devices cite the same predicate.

  • K173267MasterLoc Stem: Lateralized PlusMedacta International S.A. · 2017
  • K170845MiniMAXMedacta International S.A. · 20171 recall
  • K160289MasterLoc StemMedacta International · 2016

More from Medacta International S.A.

167 FDA decisions under this applicant name. See the company

  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254202MectaLIF 3D Metal AnteriorMedacta International S.A. · 2026
  • K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
  • K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K191145 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191145: MasterLoc Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191145

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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