510(k) Report

510(k) · Cleared

Cleared

Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467

K101240510(k) TraditionalCleared Jul 23, 201080-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

DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 23, 2010 as substantially equivalent to K091294 (DePuy Orthopaedics, Inc., 2009) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 2004. 154 later devices descend from it.

Decided
Jul 23, 2010
Review
80 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K041081 (2004). 3 ancestors in all. 154 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2013: 1 descendant cleared2012: 4 descendants cleared2014: 9 descendants cleared2017: 14 descendants cleared2025: 16 descendants cleared2020: 14 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 cleared2024: 20 descendants clearedK041081 · Fragment Plate System, Screws, Pins and K-Wires · Hand Innovations, Inc. · 2004 · recalledK061748 · Fragment Plate System · Hand Innovations, LLC · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 18 descendants3 generations forward: 38 descendants4 generations forward: 41 descendants5 generations forward: 25 descendants6 generations forward: 11 descendants7 generations forward: 7 descendants8 generations forward: 5 descendants K061748 · Fragment Plate System · Hand Innovations, LLC · 2006K041081 · Fragment Plate System, Screws, Pins and K-Wires · Hand Innovations, Inc. · 2004 · recalled0+5
  1. Root · 2 generations backK041081 Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 2004 · Recalled
  2. 1 generation backK061748 Fragment Plate SystemHand Innovations, LLC · 2006
  3. This deviceK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
  4. Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  5. Descendant · 2 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
  8. Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Showing 5 of 154 descendants. See all descendants

Descendants cleared per year

2012: 42013: 12014: 92015: 82016: 52017: 142018: 102019: 72020: 142021: 122022: 112023: 132024: 202025: 162026: 10
2012high 20 (2024) · low 1 (2013)2026

Most influential descendants

Showing 5 of 154 · See all
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 2 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
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K041081Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc.20041
−1K061748Fragment Plate SystemHand Innovations, LLC2006—
0 (this device)K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021…DePuy Orthopaedics, Inc.2010—
+1K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+2K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+3K140397Paralock Plating System / Tuffnek ScrewParagon 282014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201240
201310
201490
201580
201650
2017140
2018100
201970
2020140
2021120
2022110
2023130
2024200
2025160
2026100
FIG. 1 — Lineage of K101240, 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (2)

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
*K091294Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010…
Summary page 1
…ked Plating System is substantially equivalent to currently marketed devices including DePuy's LCL & Fusion Plating System (K091 294) and Mini Fragment Plating System (K061 748). Device Description: The DePuy ALPS Small Bone Locked Pla…
DePuy Orthopaedics, Inc.2009—
*K061748Fragment Plate System
Summary page 1
…nt to currently marketed devices including DePuy's LCL & Fusion Plating System (K091 294) and Mini Fragment Plating System (K061 748). Device Description: The DePuy ALPS Small Bone Locked Plating System consists of a series of plates a…
Hand Innovations, LLC2006—

Also cleared against K091294: 2 other devices →

What descends from it? (154)

See all 154

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

NumberDeviceApplicantDecidedDescendants
K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201297
K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.201446
K140376Variax 2 SystemStryker Trauma AG201423
K173135VariAx 2 SystemStryker GmbH201713
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
K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121
K172973Life Spine Foot and Ankle Plating 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?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K113014 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 97 descendants of its own.
  • 2 other devices also cite its predicate K091294.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The DePuy ALPS Small Bone Locked Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomny) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [> 12 -21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Indications for use as stated in the FDA summary.

Also cleared against K091294

2 other devices cite the same predicate.

  • K131670Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)Biomet, Inc. · 2013
  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 201217 recalls

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K101240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101240

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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