510(k) Report

510(k) · Cleared

Cleared

J-Screw Compression Screw

K130019510(k) TraditionalCleared Nov 18, 2014684-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

Competitive Engineering, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 18, 2014 as substantially equivalent to K990804 (Pioneer Surgical Technology, 1999) and 3 other predicates after a 684-day review. Its family tree reaches back 5 generations to 1996.

Decided
Nov 18, 2014
Review
684 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K960385 (1996). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors1999: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestorK960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 1996K022599 · Newdeal K Wire · New Deal, S.A. · 2002K070598 · Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse · Memometal Technologies · 2007K110445 · Flexfusion (TM) Fixation Implant · Nextremity Solutions, LLC · 2011 · recalledK122031 · Nextra TI Hammertoe Correction System · Nextremity Solutions, LLC · 201219952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors K122031 · Nextra TI Hammertoe Correction System · Nextremity Solutions, LLC · 2012K110445 · Flexfusion (TM) Fixation Implant · Nextremity Solutions, LLC · 2011 · recalledK070598 · Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse · Memometal Technologies · 2007K022599 · Newdeal K Wire · New Deal, S.A. · 2002K960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 1996−50
  1. Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. 4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. 3 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  4. 2 generations backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
  5. 1 generation backK122031 Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012
  6. This deviceK130019 J-Screw Compression ScrewCompetitive Engineering, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
−4K022599Newdeal K WireNew Deal, S.A.2002—
−3K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies2007—
−2K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC20116
−1K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC2012—
0 (this device)K130019J-Screw Compression ScrewCompetitive Engineering, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200520
FIG. 1 — Lineage of K130019, 1996–2014Source: 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? (4)

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 4
…gulation Number: 21 CFR 888.3040 Product Code: HWC, HTY Regulatory Class; Class II Legally Marketed StayFuse (K990804) Predicates: FlexFusion Fixation implant (K110445) Nextra Ti Hammertoe Correc…
Pioneer Surgical Technology19992
*K110445Flexfusion (TM) Fixation Implant
Summary page 4
…HWC, HTY Regulatory Class; Class II Legally Marketed StayFuse (K990804) Predicates: FlexFusion Fixation implant (K110445) Nextra Ti Hammertoe Correction System (K122031) Arthrex K-Wire (…
Nextremity Solutions, LLC20116
*K122031Nextra TI Hammertoe Correction System
Summary page 4
…StayFuse (K990804) Predicates: FlexFusion Fixation implant (K110445) Nextra Ti Hammertoe Correction System (K122031) Arthrex K-Wire (K052736) Device Description: The J-Screw is a two part bone screw f…
Nextremity Solutions, LLC2012—
*K052736Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT
Summary page 4
…FlexFusion Fixation implant (K110445) Nextra Ti Hammertoe Correction System (K122031) Arthrex K-Wire (K052736) Device Description: The J-Screw is a two part bone screw for use in osteotomy, reco…
Arthrex, Inc.2005—

Also cleared against K990804: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • 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. 2014, this device’s year, is highlighted.

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?

The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.

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
  • K130859Hammertoe Correction SystemArthrosurface, Inc. · 2013
  • K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
  • K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 20116 recalls

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/K130019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130019: J-Screw Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130019

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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