510(k) · Cleared
ClearedSynthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Nov 27, 1996 after a 65-day review. The FDA summary names its predicate without a number. 1 of the 757 devices in its family, counting itself, has a Class I recall. 756 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 65 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
756 later devices descend from it, 4 citing it directly. 1 of the 757 devices in this family, counting this one, has a Class I recall.
- This deviceK963798 Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP)…Synthes (Usa) · 1996
- Descendant · cites it directly · 749 of its ownK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- Descendant · 2 generations on · 681 of its ownK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- Descendant · 3 generations on · 678 of its ownK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- Descendant · 4 generations on · 615 of its ownK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- Descendant · 5 generations on · 606 of its ownK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
Showing 5 of 756 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub12 generations on · 2021
Most influential descendants
Showing 5 of 756 · See all- K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998 · cites it directly749descendants
- K023007Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002 · 2 generations on681descendants
- K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 3 generations on678descendants
- K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 4 generations on615descendants
- K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · 5 generations on606descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963798 | Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System | Synthes (Usa) | 1996 | — |
| +1 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| +2 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| +3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| +4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| +5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 14 | 0 |
| 2011 | 18 | 0 |
| 2012 | 19 | 0 |
| 2013 | 24 | 0 |
| 2014 | 42 | 0 |
| 2015 | 38 | 0 |
| 2016 | 32 | 0 |
| 2017 | 55 | 0 |
| 2018 | 33 | 0 |
| 2019 | 41 | 0 |
| 2020 | 47 | 0 |
| 2021 | 49 | 1 |
| 2022 | 42 | 0 |
| 2023 | 51 | 0 |
| 2024 | 69 | 0 |
| 2025 | 62 | 0 |
| 2026 | 77 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | Synthes VDRP Named without a submission number | |
| * | — | Synthes STP Named without a submission number |
What descends from it? (756)
See all 7564 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 12 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K982732 (Synthes, 1998) has gone furthest, with 749 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.
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/K963798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963798: Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963798
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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