510(k) Report

510(k) · Cleared

Cleared

Stayfuse GT-IP

K022726510(k) TraditionalCleared Sep 6, 200221-day reviewClass II21 CFR 888.3040

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

Pioneer Surgical Technology · HWC Screw, Fixation, Bone

Cleared on Sep 6, 2002 as substantially equivalent to K990804 (Pioneer Surgical Technology, 1999) after a 21-day review. Its family tree reaches back 1 generation to 1999. 65 later devices descend from it.

Decided
Sep 6, 2002
Review
21 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K990804 (1999). 65 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2017: 4 descendants cleared2010: 2 descendants cleared2012: 2 descendants cleared2015: 4 descendants cleared2019: 6 descendants cleared2020: 7 descendants cleared2013: 1 descendant cleared2021: 4 descendants cleared2018: 3 descendants cleared2022: 4 descendants cleared2025: 5 descendants cleared2023: 11 descendants cleared2024: 5 descendants cleared2026: 5 descendants clearedK990804 · Stayfuse · Pioneer Surgical Technology · 1999 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 8 descendants4 generations forward: 12 descendants5 generations forward: 15 descendants6 generations forward: 12 descendants7 generations forward: 8 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant K990804 · Stayfuse · Pioneer Surgical Technology · 1999 · recalled0+5+10
  1. Root · 1 generation backK990804 StayfusePioneer Surgical Technology · 1999 · Recalled
  2. This deviceK022726 Stayfuse GT-IPPioneer Surgical Technology · 2002
  3. Descendant · cites it directly · 63 of its ownK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
  4. Descendant · 2 generations on · 56 of its ownK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
  5. Descendant · 2 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
  6. Descendant · 3 generations on · 22 of its ownK142581 APTUS Foot SystemMedartis AG · 2015
  7. Descendant · 3 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22012: 22013: 12015: 42017: 42018: 32019: 62020: 72021: 42022: 42023: 112024: 52025: 52026: 5
2009high 11 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 65 · See all
  • K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009 · cites it directly63descendants
  • K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · 2 generations on56descendants
  • K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · 2 generations on24descendants
  • K142581APTUS Foot SystemMedartis AG · 2015 · 3 generations on22descendants
  • K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 3 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990804StayfusePioneer Surgical Technology19992
0 (this device)K022726Stayfuse GT-IPPioneer Surgical Technology2002—
+1K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC2009—
+2K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC20102
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC2017—
+3K142581APTUS Foot SystemMedartis AG2015—
+3K190586Monster® Screw SystemParagon 28, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201220
201310
201540
201740
201830
201960
202070
202140
202240
2023110
202450
202550
202650
FIG. 1 — Lineage of K022726, 1999–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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
*K990804Stayfuse
Summary page 1
…SEB 6 2002 510(k) Premarket Notification Summary Demonstrati ng S ubsta nt ia I Equiva I ence to Stay FuseTMK9 90804 August 12, 2002 Manufacturer Identification and Sponsor Pioneer Surgical Techno…
Pioneer Surgical Technology19992

Also cleared against K990804: 7 other devices →

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963
K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170

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 a recall.
  • Of its descendants, K082934 (Extremity Medical, LLC, 2009) has gone furthest, with 63 descendants of its own.
  • 7 other devices also cite its predicate K990804.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.

Indications for use as stated in the FDA summary.

Also cleared against K990804

7 other devices cite the same predicate.

  • K173616DIP Arthrodesis SystemIn2bones Sas · 2018
  • K1626852-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017
  • K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC · 2014
  • K130019J-Screw Compression ScrewCompetitive Engineering, Inc. · 2014
  • K130859Hammertoe Correction SystemArthrosurface, Inc. · 2013
  • K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012

More from Pioneer Surgical Technology

50 FDA decisions under this applicant name. See the company

  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011
  • K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
  • K101525Pioneer Spinous Process Fusion PlatePioneer Surgical Technology · 2010
  • K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
  • K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K022726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022726: Stayfuse GT-IP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022726

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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