510(k) Report

510(k) · Cleared

Cleared

Koby Surgical Internal Fixation System

K060026510(k) TraditionalCleared Jan 26, 200622-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

Koby Surgical · HWC Screw, Fixation, Bone

Cleared on Jan 26, 2006 after a 22-day review. The FDA summary names no predicate by number. 103 later devices descend from it.

Decided
Jan 26, 2006
Review
22 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

103 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2017: 9 descendants cleared2012: 2 descendants cleared2024: 11 descendants cleared2015: 7 descendants cleared2013: 2 descendants cleared2014: 2 descendants cleared2025: 9 descendants cleared2019: 7 descendants cleared2018: 1 descendant cleared2020: 11 descendants cleared2021: 6 descendants cleared2022: 10 descendants cleared2026: 10 descendants cleared2023: 14 descendants cleared20052010201520202025
  1. This deviceK060026 Koby Surgical Internal Fixation SystemKoby Surgical · 2006
  2. Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
  3. Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
  4. Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
  5. Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
  6. Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2012: 22013: 22014: 22015: 72016: 22017: 92018: 12019: 72020: 112021: 62022: 102023: 142024: 112025: 92026: 10
2012high 14 (2023) · low 1 (2018)2026

Most influential descendants

Showing 5 of 103 · See all
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · cites it directly39descendants
  • K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 2 generations on36descendants
  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 2 generations on28descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060026Koby Surgical Internal Fixation SystemKoby Surgical2006—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.20121
+2K123890Acumed Cannulated Screw SystemAcumed, LLC20132
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited20142
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201320
201420
201570
201620
201790
201810
201970
2020110
202160
2022100
2023140
2024110
202590
2026100
FIG. 1 — Lineage of K060026, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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?

The FDA summary names no predicate by number.

What descends from it? (103)

See all 103

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

NumberDeviceApplicantDecidedDescendants
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.201239
K160304OsteoBullet Compression ScrewPhalanx Innovations20168
K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171

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?

  • Of its descendants, K111678 (Ortho Solutions Limited, 2012) has gone furthest, with 58 descendants of its own.

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?

The Koby Surgical Internal Fixation System implants are intended for

fixation of fractures, non-unions, arthrodeses and osteotomies of the small

bones in the hand and foot. The implants are intended for single use only.

These implants are not intended for attachment or fixation to the posterior

elements (pedicles) of the cervical, thoracic or lumbar spine.

Indications for use as stated in the FDA summary.

Recent decisions in HWC

The HWC category page

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  • 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/K060026 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060026: Koby Surgical Internal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060026

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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