510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Locking Anatomic & Composite Plating System

K083843510(k) TraditionalCleared Mar 20, 200986-day reviewClass II21 CFR 888.3030Recalls 2

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 Mar 20, 2009 after an 86-day review. The FDA summary names no predicate by number. 106 later devices descend from it. It has been recalled 2 times.

Decided
Mar 20, 2009
Review
86 days
Class
Class II
Product code
HRS
Recalls
2
Predicates
0

106 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2025: 10 descendants cleared2016: 5 descendants cleared2018: 6 descendants cleared2020: 12 descendants cleared2021: 10 descendants cleared2026: 8 descendants cleared2022: 6 descendants cleared2015: 6 descendants cleared2014: 3 descendants cleared2019: 6 descendants cleared2017: 9 descendants cleared2023: 11 descendants cleared2024: 11 descendants cleared20052010201520202025
  1. This deviceK083843 Locking Anatomic & Composite Plating SystemDePuy Orthopaedics, Inc. · 2009
  2. Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  3. Descendant · 2 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
  4. Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  5. Descendant · 3 generations on · 24 of its ownK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
  6. Descendant · 3 generations on · 23 of its ownK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2012: 32014: 32015: 62016: 52017: 92018: 62019: 62020: 122021: 102022: 62023: 112024: 112025: 102026: 8
2012high 12 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 106 · 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
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
  • K143025Total Compression Plating SystemWrightmedicaltechnologyinc · 2014 · 3 generations on24descendants
  • K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015 · 3 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083843Locking Anatomic & Composite Plating SystemDePuy Orthopaedics, Inc.2009—
+1K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+2K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+3K143025Total Compression Plating SystemWrightmedicaltechnologyinc2014—
+3K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201430
201560
201650
201790
201860
201960
2020120
2021100
202260
2023110
2024110
2025100
202680
FIG. 1 — Lineage of K083843, 2009–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (106)

See all 106

5 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
K173767A. L. P. S. Clavicle Plating SystemBiomet, Inc.20184
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250
K162424Ulna Plating SystemBiomet, Inc.20160

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

Recalls of this device

DateClassRecallRoot causeReason
May 14, 2020Class IIZ-2308-2020Device DesignDistributed to the field without having completed design history files or design transfer activities
May 14, 2020Class IIZ-2310-2020Device DesignDistributed to the field without having completed design history files or design transfer activities

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K113014 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 97 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Locking Anatomic & Composite Plating System is intended for fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

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/K083843 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083843: Locking Anatomic & Composite Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083843

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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