510(k) · Cleared
ClearedWaveon WRX Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoma Orthopedic Products, Inc. · HRS Plate, Fixation, Bone
Cleared on Aug 28, 2009 as substantially equivalent to K071809 (Sonoma Orthopedic Products, Inc., 2008) after a 203-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Aug 28, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962616 (1996). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
- 1 generation backK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- This deviceK090304 Waveon WRX Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K042437 | Dorsal Intramedullary Plate | Deo Volente Orthopaedics, LLC | 2004 | — |
| −1 | K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2008 | — |
| 0 (this device) | K090304 | Waveon WRX Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K071809 | Ensplintrx Bone Fixation SystemSummary page 1…, Bone 21 CFR 888.3030, HRS Predicate Device Sonoma Orthopedic Products Inc. Ensplint Rx, K071809 Description of device The WavEon TM WRx configuration consists… | 2008 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K071809.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 WaveonTM WRx (WristRocketTM Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: * Joint destruction and/or subluxation visible on x-ray; * Osteotomy and repair of distal radius malunion with or without bone graft; * Non-displaced fractures. * Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3); * Transverse…
Read the full statement (140 words)
The WaveonTM WRx (WristRocketTM Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
* Joint destruction and/or subluxation visible on x-ray;
* Osteotomy and repair of distal radius malunion with or without bone graft;
* Non-displaced fractures.
* Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3);
* Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);
* Failed fracture fixation with or without bone graft for the types of fractures above;
* The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090304: Waveon WRX Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090304
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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