510(k) · Cleared
ClearedM-Vizion Monobloc
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 May 24, 2022 as substantially equivalent to K201471 (Medacta International S.A., 2021) and 5 other predicates after a 301-day review. Its family tree reaches back 11 generations to 1994. 1 later device descends from it.
- Decided
- May 24, 2022
- Review
- 301 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K921308 (1994). 49 ancestors in all, the oldest K850055 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations between
- 3 generations backK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- 2 generations backK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020
- 1 generation backK201471 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021
- This deviceK212327 M-Vizion MonoblocMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
Show all 11 generations
- Root · 11 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 10 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 9 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 8 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 7 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 6 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- 5 generations backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- 4 generations backK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
- 3 generations backK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- 2 generations backK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020
- 1 generation backK201471 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021
- This deviceK212327 M-Vizion MonoblocMedacta International S.A. · 2022
Most influential descendants
Showing 1 of 1 · See all- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −10 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −9 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −8 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −7 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −6 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| −5 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| −4 | K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015 | — |
| −3 | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
| −2 | K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2020 | — |
| −1 | K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2021 | — |
| 0 (this device) | K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022 | — |
| +1 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K201471 | M-Vizion Femoral Revision System ExtensionSummary page 4…II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: M-Vizion Femoral Revision System Extension, K201471, Medacta International SA Secondary Predicate: M-Vizion Femoral Revision System Extension, K191816, Medacta Internati… | 2021 |
| * | K191816 | M-Vizion Femoral Revision System ExtensionSummary page 4…cate: M-Vizion Femoral Revision System Extension, K201471, Medacta International SA Secondary Predicate: M-Vizion Femoral Revision System Extension, K191816, Medacta International SA M-Vizion Femoral Revision System, K170690, Medacta International SA Wagner SL Revis… | 2020 |
| * | K170690 | M-Vizion Femoral Revision SystemSummary page 4…ternational SA Secondary Predicate: M-Vizion Femoral Revision System Extension, K191816, Medacta International SA M-Vizion Femoral Revision System, K170690, Medacta International SA Wagner SL Revision Stem K953689, Zimmer Biomet Wagner SL Revision Stem Lateral K043… | 2017 |
| * | K953689 | Wagner Revision Stem (Modification)Summary page 4…ision System Extension, K191816, Medacta International SA M-Vizion Femoral Revision System, K170690, Medacta International SA Wagner SL Revision Stem K953689, Zimmer Biomet Wagner SL Revision Stem Lateral K043356, Zimmer Biomet Wagner Cone Prosthesis System K113556,… | 1995 |
| * | K043356 | Wagner SL Revision Stem LateralSummary page 4…M-Vizion Femoral Revision System, K170690, Medacta International SA Wagner SL Revision Stem K953689, Zimmer Biomet Wagner SL Revision Stem Lateral K043356, Zimmer Biomet Wagner Cone Prosthesis System K113556, Zimmer Biomet… | 2005 |
| * | K113556 | Wagner Cone Prosthesis SystemSummary page 4…onal SA Wagner SL Revision Stem K953689, Zimmer Biomet Wagner SL Revision Stem Lateral K043356, Zimmer Biomet Wagner Cone Prosthesis System K113556, Zimmer Biomet K212327… | 2012 |
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 |
|---|---|---|---|
| K260173 | M-Vizion Femoral Revision System Extension | 2026 | 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 28 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 49 ancestors have a recall of any class.
- Of its descendants, K260173 (Medacta International S.A., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K201471.
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. 2022, 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 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.
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/K212327 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212327: M-Vizion Monobloc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212327
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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