510(k) Report

510(k) · Cleared

Cleared

Uni Knee Surgetics Navigation System

K062146510(k) SpecialCleared Aug 21, 200625-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

Praxim S.A · HAW Neurological Stereotaxic Instrument

Cleared on Aug 21, 2006 as substantially equivalent to K031196 (Praxim, 2005) and 1 other predicate after a 25-day review. Its family tree reaches back 4 generations to 2000. 99 later devices descend from it.

Decided
Aug 21, 2006
Review
25 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K002053 (2000). 7 ancestors in all. 99 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 2 other ancestors2008: 3 descendants cleared2007: 2 descendants cleared2017: 10 descendants cleared2012: 3 descendants cleared2009: 2 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2021: 5 descendants cleared2013: 1 descendant cleared2015: 4 descendants cleared2023: 15 descendants cleared2022: 9 descendants cleared2025: 13 descendants cleared2020: 5 descendants cleared2024: 11 descendants cleared2026: 7 descendants cleared2016: 1 descendant cleared2019: 3 descendants cleared2018: 1 descendant clearedK002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 2000K021760 · Navitrack System-Optical TKR CT-Less, Model 900.120 · Orthosoft, Inc. · 2002K031196 · Surgetics Ortho Kneelogics Navigation System · Praxim · 2005K060282 · Total Knee Surgetics Navigation System · Praxim S.A · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 11 descendants5 generations forward: 17 descendants6 generations forward: 11 descendants7 generations forward: 7 descendants8 generations forward: 12 descendants9 generations forward: 11 descendants10 generations forward: 4 descendants11 generations forward: 3 descendants12 generations forward: 2 descendants13 generations forward: 2 descendants14 generations forward: 1 descendant15 generations forward: 1 descendant16 generations forward: 1 descendant17 generations forward: 1 descendant18 generations forward: 1 descendant K060282 · Total Knee Surgetics Navigation System · Praxim S.A · 2006K031196 · Surgetics Ortho Kneelogics Navigation System · Praxim · 2005K021760 · Navitrack System-Optical TKR CT-Less, Model 900.120 · Orthosoft, Inc. · 2002K002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 20000+5+10+15
  1. Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
  2. 3 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
  3. 2 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
  4. 1 generation backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
  5. This deviceK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
  6. Descendant · cites it directly · 79 of its ownK071714 Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007 · Recalled
  7. Descendant · cites it directly · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
  8. Descendant · 2 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
  9. Descendant · 3 generations on · 46 of its ownK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
  10. Descendant · 4 generations on · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2007: 22008: 32009: 22010: 22012: 32013: 12014: 22015: 42016: 12017: 102018: 12019: 32020: 52021: 52022: 92023: 152024: 112025: 132026: 7
2007high 15 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 99 · See all
  • K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007 · cites it directly79descendants
  • K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · cites it directly78descendants
  • K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 2 generations on76descendants
  • K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · 3 generations on46descendants
  • K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · 4 generations on44descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc.2000—
−3K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc.2002—
−2K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005—
−1K060282Total Knee Surgetics Navigation SystemPraxim S.A2006—
0 (this device)K062146Uni Knee Surgetics Navigation SystemPraxim S.A2006—
+1K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.20072
+1K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.20081
+2K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.20082
+3K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation20126
+4K143752Total Knee Application (TKA)Mako Surgical Corp.20152

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200830
200920
201020
201230
201310
201420
201540
201610
2017100
201810
201930
202050
202150
202290
2023150
2024110
2025130
202670
FIG. 1 — Lineage of K062146, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K031196Surgetics Ortho Kneelogics Navigation System
Summary page 1
…CommonlUsual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory) 3. Equivalent to: K03 1196 - Surgetics ORTHO KNEELOGICS Navigation System K060282 -TOTAL KNEE SURGETICS Navigation System 4. Intended Use:…
Praxim2005—
*K060282Total Knee Surgetics Navigation System
Summary page 1
…em Classification Name: Computed tomography x-ray system (accessory) 3. Equivalent to: K03 1196 - Surgetics ORTHO KNEELOGICS Navigation System K060282 -TOTAL KNEE SURGETICS Navigation System 4. Intended Use: The UNI KNEE SURGETICS Navigation System is intended for use…
Praxim S.A2006—

Also cleared against K031196: 2 other devices →

What descends from it? (99)

See all 99

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.200779
K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.200878
K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734

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 6 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K071714 (Orthosoft, Inc., 2007) has gone furthest, with 79 descendants of its own.
  • 2 other devices also cite its predicate K031196.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 UNI KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

It is specifically indicated for:

UniKnee Arthroplasty

Indications for use as stated in the FDA summary.

Also cleared against K031196

2 other devices cite the same predicate.

  • K053542Surgetics Ortho Osteologics Navigation SystemPraxim S.A · 2006
  • K060282Total Knee Surgetics Navigation SystemPraxim S.A · 2006

More from Praxim S.A

4 FDA decisions under this applicant name. See the company

  • K072267Total Hip Surgetics Navigation SystemPraxim S.A · 2007
  • K053542Surgetics Ortho Osteologics Navigation SystemPraxim S.A · 2006
  • K060282Total Knee Surgetics Navigation SystemPraxim S.A · 2006

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/K062146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062146: Uni Knee Surgetics Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062146

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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