510(k) · Cleared
ClearedRogachefsky Distal Radius Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 10, 1998 as substantially equivalent to K961496 (Howmedica, Inc., 1996) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1989. 203 later devices descend from it.
- Decided
- Jun 10, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885250 (1989). 2 ancestors in all. 203 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK885250 Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp. · 1989
- This deviceK981283 Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998
- Descendant · cites it directly · 202 of its ownK040022 Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004
- Descendant · 2 generations on · 157 of its ownK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 81 of its ownK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- Descendant · 2 generations on · 80 of its ownK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
- Descendant · 3 generations on · 71 of its ownK103332 Aptus Ulna PlatesMedartis AG · 2011
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 203 · See all- K040022Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004 · cites it directly202descendants
- K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · 2 generations on157descendants
- K062498Profyle SystemHowmedica Osteonics Corp. · 2006 · 2 generations on81descendants
- K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010 · 2 generations on80descendants
- K103332Aptus Ulna PlatesMedartis AG · 2011 · 3 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885250 | Alta Tibial/Upper Extremity Metaphyseal Plate Sys | Howmedica Corp. | 1989 | — |
| 0 (this device) | K981283 | Rogachefsky Distal Radius Plates | Howmedica, Inc. | 1998 | — |
| +1 | K040022 | Stryker Leibinger Universal Distal Radius System | Stryker Leibinger | 2004 | — |
| +2 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| +2 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| +2 | K100271 | Vari AX Distal Radius Line Extensions of XXL Plates | Howmedica Osteonics Corp. | 2010 | — |
| +3 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 11 | 0 |
| 2014 | 14 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 15 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 25 | 0 |
| 2025 | 19 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K961496 | R.R.P.S. Radius Reconstrution Plating SystemSummary page 1…istal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions. Equivalence for this device is based on similarities in intended… | 1996 |
| * | K885250 | Alta Tibial/Upper Extremity Metaphyseal Plate SysSummary page 1…and operational principle to the RRPS Distal Radius Plating System (Howmedica K961496) and the Alta® Tibial/Upper Extremity Plating System Metaphyseal T Plate (Howmedica K885250). o SERVICEg _/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service & REALTH «© 4, X o Food and Drug… | 1989 |
What descends from it? (203)
See all 2031 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040022 | Stryker Leibinger Universal Distal Radius System | 2004 | 202 |
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?
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 Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.
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/K981283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981283: Rogachefsky Distal Radius Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981283
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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