510(k) · Cleared
ClearedContours VSP Iii Volar Plating System
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 Oct 20, 2010 as substantially equivalent to K042766 (Orthofix, Inc., 2004) after a 100-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Oct 20, 2010
- Review
- 100 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K885250 (1989). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK885250 Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp. · 1989
- 3 generations backK981283 Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998
- 2 generations backK040022 Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004
- 1 generation backK042766 Orthofix Volar Distal Radial PlateOrthofix, Inc. · 2004
- This deviceK101936 Contours VSP Iii Volar Plating SystemOrthofix, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K885250 | Alta Tibial/Upper Extremity Metaphyseal Plate Sys | Howmedica Corp. | 1989 | — |
| −3 | K981283 | Rogachefsky Distal Radius Plates | Howmedica, Inc. | 1998 | — |
| −2 | K040022 | Stryker Leibinger Universal Distal Radius System | Stryker Leibinger | 2004 | — |
| −1 | K042766 | Orthofix Volar Distal Radial Plate | Orthofix, Inc. | 2004 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K042766 | Orthofix Volar Distal Radial PlateSummary page 1…Plate. The Volar Distal Radial Plate, manufactured by Orthofix Inc. of McKinney, TX, was originally cleared by FDA under K042766 on November 16, 2004. Device Description: The Contours VPS is an anatomically contoured, delta-shape… | 2004 |
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 21 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Contours VPS Ill Volar Plating System 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/K101936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101936: Contours VSP Iii Volar 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/K101936
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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