510(k) Report

510(k) · Cleared

Cleared

2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424

K083364510(k) SpecialCleared Dec 11, 200828-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 Dec 11, 2008 as substantially equivalent to K081546 (DePuy Orthopaedics, Inc., 2008) after a 28-day review. Its family tree reaches back 1 generation to 2008. 90 later devices descend from it.

Decided
Dec 11, 2008
Review
28 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K081546 (2008). 90 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2012: 4 descendants cleared2017: 11 descendants cleared2014: 2 descendants cleared2024: 9 descendants cleared2026: 8 descendants cleared2011: 1 descendant cleared2023: 5 descendants cleared2025: 5 descendants cleared2015: 3 descendants cleared2019: 8 descendants cleared2016: 3 descendants cleared2018: 5 descendants cleared2022: 4 descendants cleared2020: 11 descendants cleared2013: 2 descendants cleared2021: 8 descendants clearedK081546 · Small Bone Locking Plating System · DePuy Orthopaedics, Inc. · 2008 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 19 descendants4 generations forward: 24 descendants5 generations forward: 20 descendants6 generations forward: 8 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K081546 · Small Bone Locking Plating System · DePuy Orthopaedics, Inc. · 2008 · recalled0+5
  1. Root · 1 generation backK081546 Small Bone Locking Plating SystemDePuy Orthopaedics, Inc. · 2008 · Recalled
  2. This deviceK083364 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130…DePuy Orthopaedics, Inc. · 2008
  3. Descendant · cites it directly · 85 of its ownK101962 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 77 of its ownK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
  5. Descendant · 2 generations on · 64 of its ownK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  6. Descendant · 3 generations on · 38 of its ownK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  7. Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Showing 5 of 90 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 42013: 22014: 22015: 32016: 32017: 112018: 52019: 82020: 112021: 82022: 42023: 52024: 92025: 52026: 8
2010high 11 (2017) · low 1 (2010)2026

Most influential descendants

Showing 5 of 90 · See all
  • K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2010 · cites it directly85descendants
  • K111041Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011 · 2 generations on77descendants
  • K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on64descendants
  • K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · 3 generations on38descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K081546Small Bone Locking Plating SystemDePuy Orthopaedics, Inc.20081
0 (this device)K0833642.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM…DePuy Orthopaedics, Inc.2008—
+1K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.20101
+2K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.2011—
+2K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
+3K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 282014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201240
201320
201420
201530
201630
2017110
201850
201980
2020110
202180
202240
202350
202490
202550
202680
FIG. 1 — Lineage of K083364, 2008–2026Source: 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? (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
*K081546Small Bone Locking Plating System
Summary page 1
…System Name of The device is substantially equivalent to the currently marketed DePuy Predicate Small Bone Locking Plating System, K081546. Devices Classification Class II,21 CFR 888.3030 Performance Performance standards have not been est…
DePuy Orthopaedics, Inc.20081

Also cleared against K081546: 10 other devices →

What descends from it? (90)

See all 90

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

NumberDeviceApplicantDecidedDescendants
K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201085
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170
K140622DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateBiomet, Inc.20140

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, K101962 (Orthohelix Surgical Designs, Inc., 2010) has gone furthest, with 85 descendants of its own.
  • 10 other devices also cite its predicate K081546.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Small Bone Locking Plating System Line Extension is intended for 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 craniomaxillofacial skeleton, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

Also cleared against K081546

10 other devices cite the same predicate.

  • K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020
  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  • K192473Exsomed Wrist Plating SystemExsomed Corporation · 2019
  • K143749Arthrex Distal Radius SystemArthrex, Inc. · 2015
  • K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
  • K140622DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateBiomet, Inc. · 20141 recall

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/K083364 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083364: 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083364

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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