510(k) Report

510(k) · Cleared

Cleared

Imns Medacta Navigation System,33.221000US

K100314510(k) SpecialCleared Mar 31, 201055-day reviewClass II21 CFR 882.4560

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. · HAW Neurological Stereotaxic Instrument

Cleared on Mar 31, 2010 as substantially equivalent to K083872 (Medacta International S.A., 2009) after a 55-day review. Its family tree reaches back 5 generations to 2000. 13 later devices descend from it.

Decided
Mar 31, 2010
Review
55 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K002053 (2000). 11 ancestors in all. 13 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2001: 4 other ancestors2020: 2 descendants cleared2021: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant cleared2025: 4 descendants cleared2023: 2 descendants cleared2024: 1 descendant clearedK002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 2000K021760 · Navitrack System-Optical TKR CT-Less, Model 900.120 · Orthosoft, Inc. · 2002K043536 · Navitrack System - S&N Image Free Knee · Orthosoft, Inc. · 2005K061362 · Pigalileo Total Knee Replacement (TKR) System · Plus Orthopedics AG · 2006K083872 · Imns Medacta Navigation System · Medacta International S.A. · 2009200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 3 other ancestors4 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K083872 · Imns Medacta Navigation System · Medacta International S.A. · 2009K061362 · Pigalileo Total Knee Replacement (TKR) System · Plus Orthopedics AG · 2006K043536 · Navitrack System - S&N Image Free Knee · Orthosoft, Inc. · 2005K021760 · Navitrack System-Optical TKR CT-Less, Model 900.120 · Orthosoft, Inc. · 2002K002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 2000−50
  1. Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
  2. 4 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
  3. 3 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
  4. 2 generations backK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
  5. 1 generation backK083872 Imns Medacta Navigation SystemMedacta International S.A. · 2009
  6. This deviceK100314 Imns Medacta Navigation System,33.221000USMedacta International S.A. · 2010
  7. Descendant · cites it directly · 12 of its ownK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
  8. Descendant · 2 generations on · 11 of its ownK202152 NextAR TKA PlatformMedacta International S.A. · 2020
  9. Descendant · 2 generations on · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
  10. Descendant · 2 generations on · 4 of its ownK210859 NextAR™ Spine PlatformMedacta International S.A. · 2021
  11. Descendant · 3 generations on · 2 of its ownK223769 NextAR™ Spine PlatformMedacta International S.A. · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2020: 22021: 22022: 12023: 22024: 12025: 42026: 1
2020high 4 (2025) · low 1 (2022)2026

Most influential descendants

Showing 5 of 13 · See all
  • 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
  • K223769NextAR™ Spine PlatformMedacta International S.A. · 2023 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc.2000—
−4K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc.2002—
−3K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc.2005—
−2K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG2006—
−1K083872Imns Medacta Navigation SystemMedacta International S.A.2009—
0 (this device)K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.2010—
+1K193559NextAR TKA PlatformMedacta Inernational SA2020—
+2K202152NextAR TKA PlatformMedacta International S.A.2020—
+2K210153NextAR RSA PlatformMedacta International S.A.20211
+2K210859NextAR™ Spine PlatformMedacta International S.A.2021—
+3K223769NextAR™ Spine PlatformMedacta International S.A.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200140
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202120
202210
202320
202410
202540
202610
FIG. 1 — Lineage of K100314, 2000–2026Source: 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.

Planning a device in HAW? 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 HAW device

  1. #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K083872Imns Medacta Navigation System
Summary page 1
…ion Name: 21 CFR 882.4560 Class 11 Device Product Code: HAW Predicate Device: K083872 iMNS Medlacta Navigation System Product Description: The iMNS Medlacta Navigation System is a device for computer aided navigatio…
Medacta International S.A.2009—

Also cleared against K083872: 1 other device →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193559NextAR TKA PlatformMedacta Inernational SA202012

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 10 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K193559 (Medacta Inernational SA, 2020) has gone furthest, with 12 descendants of its own.
  • 1 other device also cites its predicate K083872.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HAW

9in 2025

2007: 152008: 122009: 82010: 62011: 42012: 82013: 32014: 52015: 102016: 92017: 72018: 62019: 102020: 52021: 92022: 72023: 142024: 72025: 92026 (partial year): 5
2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007: 107 days median2008: 112 days median2009: 221 days median2010: 138 days median2011: 66 days median2012: 178 days median2013: 172 days median2014: 238 days median2015: 232 days median2016: 175 days median2017: 226 days median2018: 112 days median2019: 147 days median2020: 88 days median2021: 168 days median2022: 128 days median2023: 142 days median2024: 107 days median2025: 163 days median2026 (partial year): 162 days median
2007high 238 (2014) · low 66 (2011)2026

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

Recalls per year · HAW

2in 2025

2007: 22008: 102009: 62010: 282011: 52012: 42013: 6, 1 Class I2014: 52015: 32016: 52017: 22018: 2, 2 Class I2019: 4, 1 Class I2020: 12021: 4, 2 Class I2022: 12023: 4, 1 Class I2024: 2, 2 Class I2025: 22026 (partial year): 6
2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007: 492008: 532009: 962010: 2992011: 1,7252012: 9862013: 1,2902014: 1,6062015: 1,7672016: 1,8282017: 3,5052018: 4,4392019: 6,0622020: 3,4802021: 2,8272022: 1,9292023: 2,5102024: 3,7552025: 3,425
2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, 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
200715107249
2008121121053
20098221696
2010613828299
201146651,725
201281784986
201331726 (1)1,290
2014523851,606
20151023231,767
2016917551,828
2017722623,505
201861122 (2)4,439
2019101474 (1)6,062
202058813,480
202191684 (2)2,827
2022712811,929
2023141424 (1)2,510
202471072 (2)3,755
2025916323,425
202651626—

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 Medlacta 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.

Also cleared against K083872

1 other device cites the same predicate.

  • K193559NextAR TKA PlatformMedacta Inernational SA · 2020

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 HAW

The HAW category page

  • K262214Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)Guangzhou Aimooe Technology Co., Ltd. · 2026
  • K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
  • K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
  • K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026
  • K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026

https://510kreport.com/device/K100314 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100314: Imns Medacta Navigation System,33.221000US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100314

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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