510(k) · Cleared
ClearedOrthofix Volar Distal Radial Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 16, 2004 as substantially equivalent to K040112 (Tri-Med, Inc., 2004) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Nov 16, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K885250 (1989). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK885250 Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp. · 1989
- 2 generations backK981283 Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998
- 1 generation backK040022 Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004
- This deviceK042766 Orthofix Volar Distal Radial PlateOrthofix, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK101936 Contours VSP Iii Volar Plating SystemOrthofix, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101936Contours VSP Iii Volar Plating SystemOrthofix, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885250 | Alta Tibial/Upper Extremity Metaphyseal Plate Sys | Howmedica Corp. | 1989 | — |
| −2 | K981283 | Rogachefsky Distal Radius Plates | Howmedica, Inc. | 1998 | — |
| −1 | K040022 | Stryker Leibinger Universal Distal Radius System | Stryker Leibinger | 2004 | — |
| 0 (this device) | K042766 | Orthofix Volar Distal Radial Plate | Orthofix, Inc. | 2004 | — |
| +1 | K101936 | Contours VSP Iii Volar Plating System | Orthofix, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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 |
|---|---|---|---|
| * | K040112 | Trimed Bearing Plate; Trimed Volar Bearing PlateSummary page 2…design, material, intended use, and function to two commercially available devices. The TriMed, Inc. Volar Bearing Plate, which was originally cleared by FDA under K040112 on March 12, 2004, and the Stryker Universal Distal Radius System which was originally cleared by FDA under K040022 on March… | 2004 |
| * | K040022 | Stryker Leibinger Universal Distal Radius SystemSummary page 2…Plate, which was originally cleared by FDA under K040112 on March 12, 2004, and the Stryker Universal Distal Radius System which was originally cleared by FDA under K040022 on March 12, 2004. Orthofix Inc. Prernarket Noti… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101936 | Contours VSP Iii Volar Plating System | 2010 | 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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K101936 (Orthofix, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040112.
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?
The Orthofix Volar Distal Radial Plate is intended for the volar fixation of fractures and osteotomies involving the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042766: Orthofix Volar Distal Radial Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042766
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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