510(k) · Cleared
ClearedZimmer Distal Radius Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 17, 2013 as substantially equivalent to K040022 (Stryker Leibinger, 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1989. 2 later devices descend from it.
- Decided
- Dec 17, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K885250 (1989). 11 ancestors in all. 2 later devices descend from it, 2 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 deviceK133246 Zimmer Distal Radius Plating SystemZimmer, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK182810 Distal Radius Plating SystemMiami Device Solutions, LLC · 2018
- Descendant · cites it directly · 0 of its ownK171624 IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH · 2018
Most influential descendants
Showing 2 of 2 · See allView 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) | K133246 | Zimmer Distal Radius Plating System | Zimmer, Inc. | 2013 | — |
| +1 | K182810 | Distal Radius Plating System | Miami Device Solutions, LLC | 2018 | — |
| +1 | K171624 | IXOS Radius Plate System | Stuckenbrock Medizintechnik GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K040022 | Stryker Leibinger Universal Distal Radius SystemSummary page 1…HIRS, HWC Classification Panel: Orthopedie/87 Predicate Device(s): -Stryker®o Leibinger Universal Distal Radius System, Stryker. K040022, cleared on March 12 ,h2004 - Zimmer® Periarticular Locking Plate System, Zimnir… | 2004 |
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 1…Stryker. K040022, cleared on March 12 ,h2004 - Zimmer® Periarticular Locking Plate System, Zimnir K040593, cleared on April 12tb, 2004 )3 ===… | 2004 |
What descends from it? (2)
2 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K182810 (Miami Device Solutions, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K040022.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures, fractures in osteopenic bone, non-unions, and mal-unions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133246: Zimmer Distal Radius 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/K133246
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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