510(k) Report

510(k) · Cleared

Cleared

DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System

K233665510(k) TraditionalCleared Mar 21, 2024127-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 Synthes · HRS Plate, Fixation, Bone

Cleared on Mar 21, 2024 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 10 other predicates after a 127-day review. Its family tree reaches back 12 generations to 1996. 4 later devices descend from it.

Decided
Mar 21, 2024
Review
127 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
11

Its longest line of descent runs back 12 generations to K962616 (1996). 110 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2009: 3 other ancestors2008: 4 other ancestors2006: 7 other ancestors2004: 7 other ancestors2001: 10 other ancestors2000: 9 other ancestors2011: 2 other ancestors2010: 2 other ancestors2007: 3 other ancestors2005: 6 other ancestors2003: 6 other ancestors1999: 3 other ancestors2002: 6 other ancestors1998: 3 other ancestors1996: 10 other ancestors1995: 3 other ancestors1992: 1 other ancestor1990: 1 other ancestor1994: 5 other ancestors1993: 2 other ancestors1979: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1997: 1 other ancestor2026: 2 descendants cleared2025: 2 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K112583 · Synthes Cortical Screws · Synthes (USA) Products, LLC · 2011K150099 · Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) · Synthes (USA) Products, LLC · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 17 other ancestors3 generations back: 18 other ancestors4 generations back: 20 other ancestors5 generations back: 17 other ancestors6 generations back: 11 other ancestors7 generations back: 4 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor10 generations back: 1 other ancestor 1 generation forward: 4 descendants K150099 · Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) · Synthes (USA) Products, LLC · 2015K112583 · Synthes Cortical Screws · Synthes (USA) Products, LLC · 2011K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  4. 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  5. 1 generation backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
  6. This deviceK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024
  7. Descendant · cites it directly · 0 of its ownK254093 DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026
  8. Descendant · cites it directly · 0 of its ownK260069 DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH · 2026
  9. Descendant · cites it directly · 0 of its ownK252191 BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
  10. Descendant · cites it directly · 0 of its ownK251361 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  12. 1 generation backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
  13. This deviceK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024

Most influential descendants

Showing 4 of 4 · See all
  • K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026 · cites it directly0descendants
  • K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH · 2026 · cites it directly0descendants
  • K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025 · cites it directly0descendants
  • K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−2K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
−1K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and…Synthes (USA) Products, LLC2015—
0 (this device)K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small…DePuy Synthes2024—
+1K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH2026—
+1K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH2026—
+1K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG2025—
+1K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199210
199320
199450
199530
1996100
199710
199830
199930
200090
2001100
200260
200360
200470
200560
200670
200730
200840
200930
201020
201120
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202520
202620
FIG. 1 — Lineage of K233665, 1996–2026Source: 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 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? (12)

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
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 4
…10(k) submission and therefore multiple primary predicates are identified below. Primary predicates: • K000684 - Small Fragment Dynamic Compression Locking (DCL) System • K082807 - Synthes (USA) 3.5 and 4.5 mm Locking…
Synthes (Usa)20001
*K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications
Summary page 4
…ified below. Primary predicates: • K000684 - Small Fragment Dynamic Compression Locking (DCL) System • K082807 - Synthes (USA) 3.5 and 4.5 mm Locking Compression Plate System with Expanded Indications…
Synthes (Usa)2008—
*K011335Synths One-Third Tubular DCL Plate
Summary page 4
…• K082807 - Synthes (USA) 3.5 and 4.5 mm Locking Compression Plate System with Expanded Indications • K011335 - Synthes One--Third Tubular DCL Plate • K033805 - Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates…
Synthes (Usa)20012
*K033805Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates
Summary page 4
…mpression Plate System with Expanded Indications • K011335 - Synthes One--Third Tubular DCL Plate • K033805 - Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates • K131186 - Synthes 2.7mm and 3.5mm Variable Angle LCP…
Synthes (Usa)2004—
*K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System
Summary page 4
…• K011335 - Synthes One--Third Tubular DCL Plate • K033805 - Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates • K131186 - Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System • Pre-amendm…
Synthes (USA) Products, LLC2013—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 4
….5mm Variable Angle LCP Midfoot/Hindfoot System • Pre-amendment - Synthes 4.0mm Cancellous Screws • K063049 - Synthes (USA) Modular Mini Fragment LCP System • K082072 - Synthes (USA) 3.5mm LCP Hook Plate…
Synthes (Usa)20064
*K082072Synthes (Usa) 3.5MM LCP Hook Plate
Summary page 4
…• Pre-amendment - Synthes 4.0mm Cancellous Screws • K063049 - Synthes (USA) Modular Mini Fragment LCP System • K082072 - Synthes (USA) 3.5mm LCP Hook Plate • K092247 - Synthes Locking Hand Plates • K10077…
Synthes (Usa)2008—
*K092247Synthes Locking Hand Plates
Summary page 4
…• K063049 - Synthes (USA) Modular Mini Fragment LCP System • K082072 - Synthes (USA) 3.5mm LCP Hook Plate • K092247 - Synthes Locking Hand Plates • K100776 - Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP…
Synthes (Usa)2009—
*K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System
Summary page 4
…ent LCP System • K082072 - Synthes (USA) 3.5mm LCP Hook Plate • K092247 - Synthes Locking Hand Plates • K100776 - Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System • K112583 -…
Synthes (Usa)2010—
*K112583Synthes Cortical Screws
Summary page 4
…cking Hand Plates • K100776 - Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System • K112583 - Synthes Cortical Screws • K150099 - Depuy Synthes Variable Angle Locking Hand System (1.3mm…
Synthes (USA) Products, LLC2011—
*K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
Summary page 4
…s 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System • K112583 - Synthes Cortical Screws • K150099 - Depuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) Device Descripti…
Synthes (USA) Products, LLC2015—
*—Synthes 4.0mm Cancellous Screws
Named without a submission number
—

Also cleared against K000684: 68 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260
K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260
K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250
K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250

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 28 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 20 of the 110 ancestors have a recall of any class.
  • Of its descendants, K254093 (Synthes GmbH, 2026) has gone furthest, with 0 descendants of its own.
  • 68 other devices also cite its predicate K000684.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?

DePuy Synthes VOLT™ Mini Fragment Plating System: The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by…

Read the full statement (189 words)

DePuy Synthes VOLT™ Mini Fragment Plating System:

The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Small Fragment Plating System:

The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.

Indications for use as stated in the FDA summary.

Also cleared against K000684

68 other devices cite the same predicate.

  • K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  • K242988Genostis Osteosynthesis SystemGenostis AF · 2025
  • K243469SignexOsteonic Co., Ltd. · 2025
  • K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior…Bonebridge AG · 2024
  • K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited · 2024
  • K231213HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd. · 2024

More from DePuy Synthes

19 FDA decisions under this applicant name. See the company

  • K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes · 2024
  • K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024
  • K233256Robotic Integration InstrumentsDePuy Synthes · 2024
  • K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
  • K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes · 2023

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/K233665 · printed Nov 5, 2026

Cite this page

510(k) Report. “K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment 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/K233665

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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