510(k) · Cleared
ClearedDePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 10, 2026 as substantially equivalent to K233665 (DePuy Synthes, 2024) and 1 other predicate after an 81-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Mar 10, 2026
- Review
- 81 days
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962616 (1996). 111 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 2 generations backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- 1 generation backK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024
- This deviceK254093 DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 3 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 2 generations backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- 1 generation backK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024
- This deviceK254093 DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −2 | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and… | Synthes (USA) Products, LLC | 2015 | — |
| −1 | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small… | DePuy Synthes | 2024 | — |
| 0 (this device) | K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | Synthes GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 10 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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 this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…Summary page 5…Regulation Numbers: 21 CFR §888.3030 Product Codes: HRS Predicate Device Primary Predicate Device: • K233665 - DePuy Synthes VOLT Small Fragment Plating System Additional Predicate Device:… | 2024 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 5…• K233665 - DePuy Synthes VOLT Small Fragment Plating System Additional Predicate Device: • K082807 – Synthes (USA) 3.5 and 4.5 mm Locking Compression Plate System with Expanded Indications Device Descript… | 2008 |
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 7 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 111 ancestors have a recall of any class.
- 3 other devices also cite its predicate K233665.
What is it indicated for?
The VOLT™ Medial Distal Femur 3.5 Plating System is indicated for internal fixation of isolated medial condylar fractures as a standalone fixation device. For all other distal femur fractures, corrective osteotomies, non-unions, or malunions, it is indicated for use as an adjunct to primary fixation.
The VOLT™ Medial Distal Femur 3.5 Plating System is intended for adults and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254093 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254093: DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254093
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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