510(k) · Cleared
ClearedM-Vizion Femoral Revision System
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 Nov 29, 2017 as substantially equivalent to K151739 (Lima Corporate S.P.A., 2015) and 1 other predicate after a 267-day review. Its family tree reaches back 8 generations to 1994. 5 later devices descend from it.
- Decided
- Nov 29, 2017
- Review
- 267 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921308 (1994). 46 ancestors in all, the oldest K850055 (1985). 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 6 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 5 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 3 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- 2 generations backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- 1 generation backK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
- This deviceK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- Descendant · cites it directly · 4 of its ownK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020
- Descendant · 2 generations on · 3 of its ownK201471 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021
- Descendant · cites it directly · 1 of its ownK212327 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
- Descendant · 3 generations on · 0 of its ownK220405 Amis K LongMedacta International S.A. · 2022
Most influential descendants
Showing 5 of 5 · See all- K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020 · cites it directly4descendants
- K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021 · 2 generations on3descendants
- K212327M-Vizion MonoblocMedacta International S.A. · 2022 · cites it directly1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · cites it directly0descendants
- K220405Amis K LongMedacta International S.A. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −7 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −6 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −5 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −4 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −3 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| −2 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| −1 | K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015 | — |
| 0 (this device) | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
| +1 | K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2020 | — |
| +2 | K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2021 | — |
| +1 | K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022 | — |
| +1 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +3 | K220405 | Amis K Long | Medacta International S.A. | 2022 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151739 | Revision Femoral StemSummary page 4…390 Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: x Revision Femoral Stem, K151739, Limacorporate S.p.A. x Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System, K161192, Zimmer GmbH Referenc… | 2015 |
| * | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemSummary page 4…the following devices: Primary Predicate: x Revision Femoral Stem, K151739, Limacorporate S.p.A. x Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System, K161192, Zimmer GmbH Reference Devices x MasterLoc Stem, K151531, Medacta International SA x MasterLoc Stem, K160289, Medac… | 2016 |
| † | K151531 | MasterLoc Stem | 2015 |
| † | K160289 | MasterLoc Stem | 2016 |
What descends from it? (5)
3 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?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 20 of the 46 ancestors have a recall of any class.
- Of its descendants, K191816 (Medacta International S.A., 2020) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K151739.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K170690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170690: M-Vizion Femoral Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170690
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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