510(k) · Cleared
ClearedR.R.P.S. Radius Reconstrution Plating System
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 28, 1996 after a 71-day review. The FDA summary names its predicate without a number. 204 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
204 later devices descend from it, 2 citing it directly.
- This deviceK961496 R.R.P.S. Radius Reconstrution Plating SystemHowmedica, Inc. · 1996
- Descendant · cites it directly · 203 of its ownK981283 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
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 204 · See all- K981283Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998 · cites it directly203descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961496 | R.R.P.S. Radius Reconstrution Plating System | Howmedica, Inc. | 1996 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Alta® Modular Trauma Small Bone Plating System Named without a submission number | |
| * | — | Synthes® Small Fragment and Mini Set Named without a submission number |
What descends from it? (204)
See all 2042 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K981283 (Howmedica, Inc., 1998) has gone furthest, with 203 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?
The system is intended for use in-internal fixation of small bones--primarily the distal radius in the forearm.
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/K961496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961496: R.R.P.S. Radius Reconstrution Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961496
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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