510(k) Report

510(k) · Cleared

Cleared

M-Vizion Femoral Revision System Extension

K260173510(k) TraditionalCleared Sep 17, 2026239-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 Sep 17, 2026 as substantially equivalent to K212327 (Medacta International S.A., 2022) and 10 other predicates after a 239-day review. Its family tree reaches back 20 generations to 1994. 1 of the 422 devices in its family, counting itself, has a Class I recall.

Decided
Sep 17, 2026
Review
239 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
11

Its longest line of descent runs back 20 generations to K941847 (1994). 422 ancestors in all, the oldest K800894 (1980). No later device cites it as a predicate yet. 1 of the 422 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2025: 1 other ancestor2022: 4 other ancestors2021: 4 other ancestors2020: 2 other ancestors2019: 4 other ancestors2017: 1 other ancestor2015: 2 other ancestors2011: 9 other ancestors2010: 11 other ancestors2000: 33 other ancestors, 1 with a Class I recall12016: 2 other ancestors2012: 3 other ancestors2009: 10 other ancestors2008: 14 other ancestors2007: 17 other ancestors2006: 14 other ancestors2005: 16 other ancestors2004: 17 other ancestors1998: 18 other ancestors1995: 22 other ancestors2023: 1 other ancestor2014: 1 other ancestor2013: 2 other ancestors2003: 20 other ancestors2002: 21 other ancestors2001: 20 other ancestors1999: 12 other ancestors1997: 18 other ancestors1996: 27 other ancestors1994: 26 other ancestors1992: 13 other ancestors1990: 4 other ancestors1988: 4 other ancestors1987: 6 other ancestors1986: 2 other ancestors1985: 2 other ancestors1981: 2 other ancestors1980: 2 other ancestors2018: 2 other ancestors1993: 5 other ancestors1991: 5 other ancestors1989: 1 other ancestor1984: 1 other ancestorReference device: K080885 · Medacta Total Hip Prosthesis System - Line Extension · Medacta International S.A. · 2008K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalled×2: 2 generations cleared close together, K060918 (2006), K062684 (2006) ×2: 2 generations cleared close together, K082991 (2008), K083495 (2009) K090845 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2010 · recalledK111193 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2011K113242 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2012K123991 · Depuy Corail Amt Hip Prosthesis · Depuy France S.A.S. · 2013 · recalledK150862 · DePuy Actis Duofox Hip Prosthesis · DePuy Orthopaedics, Inc. · 2015 · recalledK170339 · Summit Hip System · DePuy Orthopaedics, Inc. · 2018K193398 · Summit DuoFix HA Coating · DePuy Orthopaedics, Inc. · 2020K202472 · ACTIS Duofix Hip Prosthesis · DePuy Orthopaedics, Inc. · 2020K231873 · DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional · Depuy Ireland UC · 2024K251292 · RECLAIM Monobloc Revision Femoral Stem · Depuy Ireland UC · 202519801990200020102020
Other ancestors, by generation 1 generation back: 10 other ancestors, 1 with a Class I recall12 generations back: 19 other ancestors3 generations back: 102 other ancestors4 generations back: 92 other ancestors5 generations back: 63 other ancestors6 generations back: 31 other ancestors7 generations back: 41 other ancestors8 generations back: 24 other ancestors9 generations back: 9 other ancestors10 generations back: 8 other ancestors11 generations back: 2 other ancestors K251292 · RECLAIM Monobloc Revision Femoral Stem · Depuy Ireland UC · 2025K231873 · DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional · Depuy Ireland UC · 2024K202472 · ACTIS Duofix Hip Prosthesis · DePuy Orthopaedics, Inc. · 2020K193398 · Summit DuoFix HA Coating · DePuy Orthopaedics, Inc. · 2020K170339 · Summit Hip System · DePuy Orthopaedics, Inc. · 2018K150862 · DePuy Actis Duofox Hip Prosthesis · DePuy Orthopaedics, Inc. · 2015 · recalledK123991 · Depuy Corail Amt Hip Prosthesis · Depuy France S.A.S. · 2013 · recalledK113242 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2012K111193 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2011K090845 · Apex Arc Hip Stem · Omni Life Science, Inc. · 2010 · recalledK083495 · Modification to: Metha Hip System · Aesculap Implant Systems, Inc. · 2009K082991 · Biolox Delta Ceramic Femoral Head · Aesculap Implant Systems, Inc. · 2008K062684 · Excia Total Hip System 36MM Ceramic Head · Aesculap, Inc. · 2006K060918 · Excia Total Hip System 12/14 Trunnion with Ceramic Head · Aesculap, Inc. · 2006K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994−20−15−10−50
  1. Root · 20 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 16 generations between
  3. 3 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
  4. 2 generations backK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
  5. 1 generation backK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
  6. This deviceK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
Show all 20 generations
  1. Root · 20 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 19 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. 18 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
  4. 17 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
  5. 16 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  6. 15 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. 14 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  8. 13 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
  9. 12 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
  10. 11 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
  11. 10 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
  12. 9 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
  13. 8 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
  14. 7 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
  15. 6 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
  16. 5 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
  17. 4 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
  18. 3 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
  19. 2 generations backK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
  20. 1 generation backK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
  21. This deviceK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026

Class I recalls in this family

  • K003016 Pro-Femur Rdirect predicate · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−19K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
−18K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19981
−17K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000—
−16K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
−15K042344Excia Total Hip SystemAesculap, Inc.200510
−14K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.2006—
−13K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.2006—
−12K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.2008—
−11K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.2009—
−10K090845Apex Arc Hip StemOmni Life Science, Inc.20102
−9K111193Apex Arc Hip StemOmni Life Science, Inc.2011—
−8K113242Apex Arc Hip StemOmni Life Science, Inc.2012—
−7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.20131
−6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.20151
−5K170339Summit Hip SystemDePuy Orthopaedics, Inc.2018—
−4K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.2020—
−3K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.2020—
−2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC2024—
−1K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC2025—
0 (this device)K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
198120
198410
198520
198620
198760
198840
198910
199040
199150
1992130
199350
1994260
1995220
1996270
1997180
1998180
1999120
2000331
2001200
2002210
2003200
2004170
2005160
2006140
2007170
2008140
2009100
2010110
201190
201230
201320
201410
201520
201620
201710
201820
201940
202020
202140
202240
202310
202510
FIG. 1 — Lineage of K260173, 1994–2026Source: 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.

1 device in this family has a Class I recall. 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? (11)

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
*K212327M-Vizion Monobloc
Summary page 6
…ication II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • M-Vizion Monobloc, K212327, Medacta International SA Additional Predicate devices: • M-Vizion Femoral Revision System Extension, K191816, Medacta In…
Medacta International S.A.2022—
*K191816M-Vizion Femoral Revision System Extension
Summary page 6
…imary Predicate device: • M-Vizion Monobloc, K212327, Medacta International SA Additional Predicate devices: • M-Vizion Femoral Revision System Extension, K191816, Medacta International SA • M-Vizion Femoral Revision System, K170690, Medacta International SA • MectaCer Biolox D…
Medacta International S.A.2020—
*K170690M-Vizion Femoral Revision System
Summary page 6
…ional SA Additional Predicate devices: • M-Vizion Femoral Revision System Extension, K191816, Medacta International SA • M-Vizion Femoral Revision System, K170690, Medacta International SA • MectaCer Biolox Delta Heads, K112115, Medacta International SA • REDAPTTM Revision Femo…
Medacta International S.A.2017—
*K112115Mectacer Biolox (R) Delta Femoral Heads
Summary page 6
…on System Extension, K191816, Medacta International SA • M-Vizion Femoral Revision System, K170690, Medacta International SA • MectaCer Biolox Delta Heads, K112115, Medacta International SA • REDAPTTM Revision Femoral System, K151902, SMITH & NEPHEW, INC. • Reclaim Revision Hip…
Medacta International2011—
*K151902REDAPT¿ Revision Femoral System
Summary page 6
…ral Revision System, K170690, Medacta International SA • MectaCer Biolox Delta Heads, K112115, Medacta International SA • REDAPTTM Revision Femoral System, K151902, SMITH & NEPHEW, INC. • Reclaim Revision Hip System, K102080, DEPUY • Pro-femur R, K003016, Wright Medical Technolo…
Smith & Nephew, Inc.2015—
*K102080Depuy Reclaim Revision Hip System
Summary page 6
…aCer Biolox Delta Heads, K112115, Medacta International SA • REDAPTTM Revision Femoral System, K151902, SMITH & NEPHEW, INC. • Reclaim Revision Hip System, K102080, DEPUY • Pro-femur R, K003016, Wright Medical Technology, Inc • Mpact Constrained Liner, K241461, Medacta Internati…
Depuy (Ireland)20103
*K003016Pro-Femur R
Summary page 6
…acta International SA • REDAPTTM Revision Femoral System, K151902, SMITH & NEPHEW, INC. • Reclaim Revision Hip System, K102080, DEPUY • Pro-femur R, K003016, Wright Medical Technology, Inc • Mpact Constrained Liner, K241461, Medacta International SA…
Wrightmedicaltechnologyinc2000Class I
*K241461Mpact Constrained Liner
Summary page 6
…SMITH & NEPHEW, INC. • Reclaim Revision Hip System, K102080, DEPUY • Pro-femur R, K003016, Wright Medical Technology, Inc • Mpact Constrained Liner, K241461, Medacta International SA…
Medacta International S.A.2025—
*K183141LINK MP Monoblock Hip Prosthesis
Summary page 7
…2 of 4 M-Vizion Femoral Revision System Extension Medacta International SA Traditional 510(k) • LINK MP Monoblock Hip Prosthesis, K183141, Waldemar Link GmbH & Co. KG • RECLAIM Monobloc Revision Femoral Stem, K251292, Depuy Ireland UC • M-Vizion Fem…
Waldemar Link GmbH & Co. KG201912
*K251292RECLAIM Monobloc Revision Femoral Stem
Summary page 7
…International SA Traditional 510(k) • LINK MP Monoblock Hip Prosthesis, K183141, Waldemar Link GmbH & Co. KG • RECLAIM Monobloc Revision Femoral Stem, K251292, Depuy Ireland UC • M-Vizion Femoral Revision System Extension, K201471, Medacta International SA Reference Devices:…
Depuy Ireland UC2025—
*K201471M-Vizion Femoral Revision System Extension
Summary page 7
…K183141, Waldemar Link GmbH & Co. KG • RECLAIM Monobloc Revision Femoral Stem, K251292, Depuy Ireland UC • M-Vizion Femoral Revision System Extension, K201471, Medacta International SA Reference Devices: • Medacta Total Hip Prosthesis System - Line Extension, K080885, Medacta Int…
Medacta International S.A.2021—
†K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A.2008—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K003016Pro-Femur RWrightmedicaltechnologyinc · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
  • 113 of the 421 ancestors have a recall of any class; 1 has a Class I recall.

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. 2026, 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?

M-Vizion The hip prosthesis M-Vizion 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…

Read the full statement (387 words)

M-Vizion

The hip prosthesis M-Vizion 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.

Mpact Constrained Liner

Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells.

Total Hip Arthroplasty is indicated in the following cases:

» Severely painful and/or disabled joint as a result of arthrosis, 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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.

Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components.

MectaCer Biolox® Delta Head

The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX®delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient’s condition should be due to one or more of the following:

» Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rhreumatoid arthritis, or psoriatic arthritis,

» Congenital hip dysplasia,

» Ankylosing spondylitis,

» 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 where sufficient bone stock is present.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medacta International S.A.

167 FDA decisions under this applicant name. See the company

  • 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
  • K250644MSS - Monobloc stemMedacta International S.A. · 20261 recall

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 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
  • K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K260173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260173: M-Vizion Femoral Revision System Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260173

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026