510(k) · Cleared
ClearedVolar Distal Radius Plate
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 Mar 8, 1996 after a 217-day review. The FDA summary names its predicate without a number. 438 later devices descend from it.
- Decided
- Mar 8, 1996
- Review
- 217 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
438 later devices descend from it, 7 citing it directly.
- This deviceK953644 Volar Distal Radius PlateSynthes (Usa) · 1996
- Descendant · cites it directly · 419 of its ownK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- Descendant · 2 generations on · 413 of its ownK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- Descendant · 2 generations on · 337 of its ownK012001 SmartscrewBionx Implants, Ltd. · 2001
- Descendant · 3 generations on · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- Descendant · 4 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Showing 5 of 438 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 438 · See all- K974876Bionx Distal Radius ScrewBionx Implants, Inc. · 1998 · cites it directly419descendants
- K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999 · 2 generations on413descendants
- K012001SmartscrewBionx Implants, Ltd. · 2001 · 2 generations on337descendants
- K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · 3 generations on333descendants
- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 4 generations on306descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953644 | Volar Distal Radius Plate | Synthes (Usa) | 1996 | — |
| +1 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| +2 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| +2 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| +3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| +4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 3 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 20 | 0 |
| 2015 | 11 | 0 |
| 2016 | 8 | 0 |
| 2017 | 23 | 0 |
| 2018 | 21 | 0 |
| 2019 | 35 | 0 |
| 2020 | 31 | 0 |
| 2021 | 26 | 0 |
| 2022 | 29 | 0 |
| 2023 | 36 | 0 |
| 2024 | 39 | 0 |
| 2025 | 40 | 0 |
| 2026 | 38 | 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? (1)
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 Small T-Plate Named without a submission number |
What descends from it? (438)
See all 4387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974876 | Bionx Distal Radius Screw | 1998 | 419 |
| K972219 | Orthopedic Plate System | 1997 | 8 |
| K110125 | 2.4 MM VA-LCP Volar Rim Distal Radius System | 2011 | 5 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS… | 2018 | 2 |
| K981715 | Distal Radius Fracture Fixation Plate | 1998 | 1 |
| K990596 | Distal Radius Fracture Fixation Plate System | 1999 | 0 |
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?
- Of its descendants, K974876 (Bionx Implants, Inc., 1998) has gone furthest, with 419 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 Volar Distal Radius Plate 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/K953644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953644: Volar Distal Radius Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953644
Report an extraction error
Are you the manufacturer?
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