510(k) · Cleared
ClearedImns Medacta Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jan 15, 2009 as substantially equivalent to K061362 (Plus Orthopedics AG, 2006) after a 17-day review. Its family tree reaches back 4 generations to 2000. 14 later devices descend from it.
- Decided
- Jan 15, 2009
- Review
- 17 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002053 (2000). 10 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 3 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 2 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 1 generation backK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
- This deviceK083872 Imns Medacta Navigation SystemMedacta International S.A. · 2009
- Descendant · cites it directly · 13 of its ownK100314 Imns Medacta Navigation System,33.221000USMedacta International S.A. · 2010
- Descendant · cites it directly · 12 of its ownK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- Descendant · 2 generations on · 11 of its ownK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- Descendant · 2 generations on · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
- Descendant · 2 generations on · 4 of its ownK210859 NextAR™ Spine PlatformMedacta International S.A. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K100314Imns Medacta Navigation System,33.221000USMedacta International S.A. · 2010 · cites it directly13descendants
- K193559NextAR TKA PlatformMedacta Inernational SA · 2020 · cites it directly12descendants
- K202152NextAR TKA PlatformMedacta International S.A. · 2020 · 2 generations on11descendants
- K210153NextAR RSA PlatformMedacta International S.A. · 2021 · 2 generations on5descendants
- K210859NextAR™ Spine PlatformMedacta International S.A. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −3 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −2 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −1 | K061362 | Pigalileo Total Knee Replacement (TKR) System | Plus Orthopedics AG | 2006 | — |
| 0 (this device) | K083872 | Imns Medacta Navigation System | Medacta International S.A. | 2009 | — |
| +1 | K100314 | Imns Medacta Navigation System,33.221000US | Medacta International S.A. | 2010 | — |
| +1 | K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020 | — |
| +2 | K202152 | NextAR TKA Platform | Medacta International S.A. | 2020 | — |
| +2 | K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 | 1 |
| +2 | K210859 | NextAR™ Spine Platform | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K061362 | Pigalileo Total Knee Replacement (TKR) SystemSummary page 1…on Name: 21 CFR 882.4560 Class II Device Product Code: HAW Predicate Device: K061362 PiGalileo TM Total Knee Replacement (TKR) System Product Description: The iMNS Medacta Navigation System is… | 2006 |
What descends from it? (14)
See all 142 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 9 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K100314 (Medacta International S.A., 2010) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K061362.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The iMNS Medacta Navigation System is intended to be used to support the
surgeon during specific orthopedic surgical procedures by providing
information on bone resections, instrument and implant positioning during
joint replacement.
The iMNS Medacta Navigation System provides computer assistance to the
surgeon based on anatomical landmarks and other specific data obtained
intra-operatively that are used to place surgical instruments.
Examples of some surgical procedures include but are not limited to:
Total Knee Replacement
Minimally Invasive Total Knee Replacement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083872: Imns Medacta Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083872
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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