510(k) · Cleared
ClearedVOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes GmbH · HRS Plate, Fixation, Bone
Cleared on Mar 2, 2026 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 3 other predicates after a 75-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Mar 2, 2026
- Review
- 75 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K962616 (1996). 38 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK060041 Trimed Bone PlatesTriMed, Inc. · 2006 · Recalled
- 2 generations backK141430 Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014
- 1 generation backK211051 DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini…DePuy Synthes · 2021
- This deviceK254054 VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7…Synthes GmbH · 2026
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK060041 Trimed Bone PlatesTriMed, Inc. · 2006 · Recalled
- 2 generations backK141430 Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014
- 1 generation backK211051 DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini…DePuy Synthes · 2021
- This deviceK254054 VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7…Synthes GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K060041 | Trimed Bone Plates | TriMed, Inc. | 2006 | 3 |
| −2 | K141430 | Variax Distal Radius Plating System | Stryker Leibinger GmbH & Co KG | 2014 | — |
| −1 | K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment… | DePuy Synthes | 2021 | — |
| 0 (this device) | K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System | Synthes GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 5…dered as primary predicates as this is a bundled traditional 510(k) submission. Primary Predicate Devices: • K011335 - Synthes One-Third Tubular DCL Plate • K991407 - Synthes Locking Calcaneal Plates • K063… | 2001 |
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 5…traditional 510(k) submission. Primary Predicate Devices: • K011335 - Synthes One-Third Tubular DCL Plate • K991407 - Synthes Locking Calcaneal Plates • K063049 - Synthes (USA) Modular Mini Fragment LCP System… | 1999 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 5…icate Devices: • K011335 - Synthes One-Third Tubular DCL Plate • K991407 - Synthes Locking Calcaneal Plates • K063049 - Synthes (USA) Modular Mini Fragment LCP System • K211051 - DePuy Synthes 2.7mm Straight and 2.7mm Adaption… | 2006 |
| * | K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)Summary page 5…ate • K991407 - Synthes Locking Calcaneal Plates • K063049 - Synthes (USA) Modular Mini Fragment LCP System • K211051 - DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates Device VOLTTM Ankle Trauma 2.7/3.5 Plating System Descripti… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 11 of the 38 ancestors have a recall of any class.
- 42 other devices also cite its predicate K011335.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The VOLT™ Ankle Trauma 2.7/3.5 Plating System is indicated for fractures, non-unions and deformity corrections in the distal tibia and distal fibula.
The VOLT™ Ankle Trauma 2.7/3.5 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.
The VOLT™ Calcaneus 2.7 Plating System is indicated for fractures, non-unions and deformity corrections in the calcaneus
The VOLT™ Calcaneus 2.7 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254054: VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254054
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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