510(k) Report

510(k) · Cleared

Cleared

Fragment Plate System

K061748510(k) SpecialCleared Jul 17, 200626-day reviewClass II21 CFR 888.3030

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

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

Cleared on Jul 17, 2006 as substantially equivalent to K041081 (Hand Innovations, Inc., 2004) after a 26-day review. Its family tree reaches back 1 generation to 2004. 157 later devices descend from it.

Decided
Jul 17, 2006
Review
26 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K041081 (2004). 157 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2012: 4 descendants cleared2017: 15 descendants cleared2010: 1 descendant cleared2014: 9 descendants cleared2025: 16 descendants cleared2018: 10 descendants cleared2023: 13 descendants cleared2016: 5 descendants cleared2022: 11 descendants cleared2019: 7 descendants cleared2015: 8 descendants cleared2021: 12 descendants cleared2026: 10 descendants cleared2020: 14 descendants cleared2024: 20 descendants clearedK041081 · Fragment Plate System, Screws, Pins and K-Wires · Hand Innovations, Inc. · 2004 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 17 descendants3 generations forward: 27 descendants4 generations forward: 29 descendants5 generations forward: 33 descendants6 generations forward: 22 descendants7 generations forward: 10 descendants8 generations forward: 7 descendants9 generations forward: 5 descendants K041081 · Fragment Plate System, Screws, Pins and K-Wires · Hand Innovations, Inc. · 2004 · recalled0+5
  1. Root · 1 generation backK041081 Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 2004 · Recalled
  2. This deviceK061748 Fragment Plate SystemHand Innovations, LLC · 2006
  3. Descendant · cites it directly · 154 of its ownK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
  4. Descendant · 2 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  5. Descendant · 3 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
  6. Descendant · cites it directly · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  7. Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled

Showing 5 of 157 descendants. See all descendants

Descendants cleared per year

2010: 12012: 42013: 22014: 92015: 82016: 52017: 152018: 102019: 72020: 142021: 122022: 112023: 132024: 202025: 162026: 10
2010high 20 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 157 · See all
  • K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…DePuy Orthopaedics, Inc. · 2010 · cites it directly154descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 2 generations on97descendants
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 3 generations on95descendants
  • K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · cites it directly46descendants
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K041081Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc.20041
0 (this device)K061748Fragment Plate SystemHand Innovations, LLC2006—
+1K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021…DePuy Orthopaedics, Inc.2010—
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+3K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201240
201320
201490
201580
201650
2017150
2018100
201970
2020140
2021120
2022110
2023130
2024200
2025160
2026100
FIG. 1 — Lineage of K061748, 2004–2026Source: 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 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 21.3 · 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
*K041081Fragment Plate System, Screws, Pins and K-Wires
Summary page 1
…nt Plates IPlate Fixation Bone Name of The device is substantially equivalent to: Predicate *Fragment Plate System (510(k) # K041081 -July1, 20043) -HandlInnovations, Devices LLC. Classification Class II. Performance Performance standa…
Hand Innovations, Inc.20041

Also cleared against K041081: 2 other devices →

What descends from it? (157)

See all 157

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

NumberDeviceApplicantDecidedDescendants
K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…DePuy Orthopaedics, Inc.2010154
K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.201446
K131670Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)Biomet, Inc.20135
K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH20141
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170
K1318672.5MM Inline Fusion PlateBiomet, Inc.20130

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, K101240 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 154 descendants of its own.
  • 2 other devices also cite its predicate K041081.

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

reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe,

pelvis, and craniomax, illofacial skeleton.

Indications for use as stated in the FDA summary.

Also cleared against K041081

2 other devices cite the same predicate.

  • K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 20141 recall
  • K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 20051 recall

More from Hand Innovations, LLC

7 FDA decisions under this applicant name. See the company

  • K060864Multidirectional Threaded PegHand Innovations, LLC · 2006
  • K060294Diaphyseal PlateHand Innovations, LLC · 2006
  • K060290Shoulder Fixation SystemHand Innovations, LLC · 2006
  • K052294Shoulder Nail PlateHand Innovations, LLC · 2005
  • K052248Dorsal Nail Plate, AnatomicalHand Innovations, LLC · 20055 recalls

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/K061748 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061748: Fragment Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061748

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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