510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Fragment Plate System, Screws, Pins and K-Wires

K041081510(k) TraditionalCleared Jul 1, 200466-day reviewClass II21 CFR 888.3030Recalls 1

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

Hand Innovations, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jul 1, 2004 after a 66-day review. The FDA summary names its predicate without a number. 257 later devices descend from it. It has been recalled once.

Decided
Jul 1, 2004
Review
66 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
0

257 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2014: 17 descendants cleared2006: 2 descendants cleared2023: 21 descendants cleared2025: 22 descendants cleared2022: 15 descendants cleared2018: 15 descendants cleared2016: 10 descendants cleared2019: 13 descendants cleared2020: 20 descendants cleared2012: 6 descendants cleared2026: 21 descendants cleared2010: 4 descendants cleared2011: 3 descendants cleared2017: 24 descendants cleared2015: 9 descendants cleared2021: 14 descendants cleared2013: 7 descendants cleared2008: 1 descendant cleared2024: 31 descendants cleared2009: 1 descendant cleared200020052010201520202025
  1. This deviceK041081 Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 2004
  2. Descendant · cites it directly · 157 of its ownK061748 Fragment Plate SystemHand Innovations, LLC · 2006
  3. Descendant · cites it directly · 157 of its ownK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 154 of its ownK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
  5. Descendant · 3 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  6. Descendant · 4 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 257 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22008: 12009: 12010: 42011: 32012: 62013: 72014: 172015: 92016: 102017: 242018: 152019: 132020: 202021: 142022: 152023: 212024: 312025: 222026: 21
2005high 31 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 257 · See all
  • K061748Fragment Plate SystemHand Innovations, LLC · 2006 · cites it directly157descendants
  • K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · cites it directly157descendants
  • K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…DePuy Orthopaedics, Inc. · 2010 · 2 generations on154descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 3 generations on97descendants
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 4 generations on95descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041081Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc.2004—
+1K061748Fragment Plate SystemHand Innovations, LLC2006—
+1K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051
+2K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021…DePuy Orthopaedics, Inc.2010—
+3K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+4K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200810
200910
201040
201130
201260
201370
2014170
201590
2016100
2017240
2018150
2019130
2020200
2021140
2022150
2023210
2024310
2025220
2026210
FIG. 1 — Lineage of K041081, 2004–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.4 · 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
*—Distal Volar Fracture Repair System
Named without a submission number
—

What descends from it? (257)

See all 257

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

NumberDeviceApplicantDecidedDescendants
K061748Fragment Plate SystemHand Innovations, LLC2006157
K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.2005157
K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH20141

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 23, 2014Class IIZ-2212-2014Nonconforming Material/ComponentThe firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061748 (Hand Innovations, LLC, 2006) has gone furthest, with 157 descendants of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

Indications for use as stated in the FDA summary.

More from Hand Innovations, Inc.

10 FDA decisions under this applicant name. See the company

  • K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 20051 recall
  • K042059Shoulder Fixation SystemHand Innovations, Inc. · 2004
  • K041157Modification to Small Bone Fixation SystemHand Innovations, Inc. · 2004
  • K033406Small Bone Fixation SystemHand Innovations, Inc. · 2004
  • K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K041081 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041081: Fragment Plate System, Screws, Pins and K-Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041081

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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