510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna Plate

K140622510(k) TraditionalCleared May 13, 201463-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

Biomet, Inc. · HRS Plate, Fixation, Bone

Cleared on May 13, 2014 as substantially equivalent to K081546 (DePuy Orthopaedics, Inc., 2008) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 2008. It has been recalled once.

Decided
May 13, 2014
Review
63 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
3

Its longest line of descent runs back 2 generations to K081546 (2008). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestorK081546 · Small Bone Locking Plating System · DePuy Orthopaedics, Inc. · 2008 · recalledK083364 · 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424 · DePuy Orthopaedics, Inc. · 2008200620082010201220142016
Other ancestors, by generation 1 generation back: 1 other ancestor K083364 · 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424 · DePuy Orthopaedics, Inc. · 2008K081546 · Small Bone Locking Plating System · DePuy Orthopaedics, Inc. · 2008 · recalled0
  1. Root · 2 generations backK081546 Small Bone Locking Plating SystemDePuy Orthopaedics, Inc. · 2008 · Recalled
  2. 1 generation backK083364 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130…DePuy Orthopaedics, Inc. · 2008
  3. This deviceK140622 DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateBiomet, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K081546Small Bone Locking Plating SystemDePuy Orthopaedics, Inc.20081
−1K0833642.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM…DePuy Orthopaedics, Inc.2008—
0 (this device)K140622DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateBiomet, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K140622, 2008–2014Source: 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? (3)

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
…l, Lateral and Ulna Plating System is substantially equivalent to the currently marketed Small Bone Locking Plating System (K081546, K083364) and Distal Volar Radius Plating System (K112345). Device Description: The Dorsal, Lateral an…
DePuy Orthopaedics, Inc.20081
*K0833642.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking…
Summary page 1
…l and Ulna Plating System is substantially equivalent to the currently marketed Small Bone Locking Plating System (K081546, K083364) and Distal Volar Radius Plating System (K112345). Device Description: The Dorsal, Lateral and Ulna Pl…
DePuy Orthopaedics, Inc.2008—
*K112345Distal Volar Radius Plating Systems
Summary page 1
…lent to the currently marketed Small Bone Locking Plating System (K081546, K083364) and Distal Volar Radius Plating System (K112345). Device Description: The Dorsal, Lateral and Ulna Plating System consists of Titanium alloy plates ut…
Medos International SARL20114

Also cleared against K081546: 10 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 29, 2016Class IIZ-1082-2016Package design/selectionComponents of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • 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. 2014, 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 system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, 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
  • K140372Fragment Plate SystemSkeletal Dynamics, LLC · 2014

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K140622 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140622: DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140622

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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