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
Avanta Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 29, 1999 as substantially equivalent to K943853 (Wrightmedicaltechnologyinc, 1995) and 2 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Apr 29, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943853 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943853 | Distal Radius Fracture Fixation Plate System | Wrightmedicaltechnologyinc | 1995 | — |
| −1 | K981715 | Distal Radius Fracture Fixation Plate | Avanta Orthopaedics, Inc. | 1998 | — |
| 0 (this device) | K990596 | Distal Radius Fracture Fixation Plate System | Avanta Orthopaedics, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (3)
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 |
|---|---|---|---|
| * | K943853 | Distal Radius Fracture Fixation Plate SystemSummary page 1…8580 619-452-9945 Louise M. Focht Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Plate System Class II Orthopaedic 888.3030 87HRS Orthomet K943853 Synthes K953644 Avanta K981715 Device Description: Distal Radius Fracture Fixation The distal radius plate like the predicate… | 1995 |
| * | K953644 | Volar Distal Radius PlateSummary page 1…5 Louise M. Focht Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Plate System Class II Orthopaedic 888.3030 87HRS Orthomet K943853 Synthes K953644 Avanta K981715 Device Description: Distal Radius Fracture Fixation The distal radius plate like the predicate device includes… | 1996 |
| * | K981715 | Distal Radius Fracture Fixation PlateSummary page 1…ht Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Plate System Class II Orthopaedic 888.3030 87HRS Orthomet K943853 Synthes K953644 Avanta K981715 Device Description: Distal Radius Fracture Fixation The distal radius plate like the predicate device includes various size pl… | 1998 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K943853.
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 intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone,
Failed fracture fixation with or without bone graft,
Osteotomy and repair of distal radius malunion with or without bone graft.
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/K990596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990596: 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/K990596
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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