510(k) · Cleared
ClearedDistal Radius Fracture Fixation Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on Jan 20, 1995 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jan 20, 1995
- Review
- 165 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK943853 Distal Radius Fracture Fixation Plate SystemWrightmedicaltechnologyinc · 1995
- Descendant · cites it directly · 1 of its ownK981715 Distal Radius Fracture Fixation PlateAvanta Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK990596 Distal Radius Fracture Fixation Plate SystemAvanta Orthopaedics, Inc. · 1999
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 |
|---|---|---|---|---|---|
| 0 (this device) | K943853 | Distal Radius Fracture Fixation Plate System | Wrightmedicaltechnologyinc | 1995 | — |
| +1 | K981715 | Distal Radius Fracture Fixation Plate | Avanta Orthopaedics, Inc. | 1998 | — |
| +1 | K990596 | Distal Radius Fracture Fixation Plate System | Avanta Orthopaedics, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K981715 (Avanta Orthopaedics, Inc., 1998) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K943853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943853: Distal Radius Fracture Fixation Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943853
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026