510(k) Report

510(k) · Cleared

Cleared

Surgetics Entact Endonasal Navigation System

K022239510(k) TraditionalCleared Aug 23, 200243-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Praxim · JAK System, X-Ray, Tomography, Computed

Cleared on Aug 23, 2002 as substantially equivalent to K000310 (Philips Medical Systems (Cleveland), Inc., 2000) after a 43-day review. Its family tree reaches back 1 generation to 2000. 35 later devices descend from it.

Decided
Aug 23, 2002
Review
43 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000310 (2000). 35 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2017: 3 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2021: 2 descendants cleared2023: 8 descendants cleared2022: 2 descendants cleared2020: 1 descendant cleared2024: 6 descendants cleared2025: 6 descendants cleared2026: 4 descendants clearedK000310 · Voyager 6.0 Software Option · Philips Medical Systems (Cleveland), Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 5 descendants5 generations forward: 11 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants9 generations forward: 3 descendants K000310 · Voyager 6.0 Software Option · Philips Medical Systems (Cleveland), Inc. · 20000+5
  1. Root · 1 generation backK000310 Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc. · 2000
  2. This deviceK022239 Surgetics Entact Endonasal Navigation SystemPraxim · 2002
  3. Descendant · cites it directly · 34 of its ownK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
  4. Descendant · 2 generations on · 18 of its ownK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
  5. Descendant · 3 generations on · 17 of its ownK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
  6. Descendant · 2 generations on · 15 of its ownK162567 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · Recalled
  7. Descendant · 3 generations on · 14 of its ownK173372 ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · Recalled

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 12017: 32020: 12021: 22022: 22023: 82024: 62025: 62026: 4
2007high 8 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 35 · See all
  • K063408Ctlogics Navigations SystemsPraxim Medivision, SA · 2007 · cites it directly34descendants
  • K081232Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008 · 2 generations on18descendants
  • K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · 3 generations on17descendants
  • K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · 2 generations on15descendants
  • K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000310Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc.2000—
0 (this device)K022239Surgetics Entact Endonasal Navigation SystemPraxim2002—
+1K063408Ctlogics Navigations SystemsPraxim Medivision, SA2007—
+2K081232Total Knee Surgetics Navigation System with PraxitelesPraxim2008—
+3K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA20102
+2K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho20171
+3K173372ExactechGPS Total Shoulder ApplicationBlue Ortho20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201010
201730
202010
202120
202220
202380
202460
202560
202640
FIG. 1 — Lineage of K022239, 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 JAK? 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 JAK device

  1. #1 K230223 iCAC Devicescore 23.5 · 12 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
*K000310Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc.2000—

Also cleared against K000310: 2 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
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?

  • Its one ancestor has no recall.
  • Of its descendants, K063408 (Praxim Medivision, SA, 2007) has gone furthest, with 34 descendants of its own.
  • 2 other devices also cite its predicate K000310.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

The Surgetics ENTact Endonasal Navigation System is intended for use as an aid to the surgeon for precisely locating anatomical structures either during open or percutaneous ENT/endonasal or sinus procedures.

Indications for use as stated in the FDA summary.

Also cleared against K000310

2 other devices cite the same predicate.

  • K023975Voyager LinuxZ-Kat, Inc. · 2002
  • K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001

More from Praxim

3 FDA decisions under this applicant name. See the company

  • K081232Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
  • K031196Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K022239 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022239: Surgetics Entact Endonasal 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/K022239

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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