510(k) · Cleared
ClearedRIVAL View Plating Systems and Reduce Fracture Plating Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · HRS Plate, Fixation, Bone
Cleared on Jun 7, 2019 as substantially equivalent to K140876 (Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic, 2014) after a 108-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Jun 7, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022325 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
- 2 generations backK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
- 1 generation backK140876 View Plating System,Reduce Fracture Plating System,Bone ScrewIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic · 2014 · Recalled
- This deviceK190388 RIVAL View Plating Systems and Reduce Fracture Plating SystemsOrthofix Srl · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022325 | Normed Titanium Osteotomy Plating System | Osteomedics, Inc. | 2002 | 1 |
| −2 | K061808 | Darco Locking Bone Plate System | Darco International, Inc. | 2006 | 3 |
| −1 | K140876 | View Plating System,Reduce Fracture Plating System,Bone Screw | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014 | 15 |
| 0 (this device) | K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems | Orthofix Srl | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K140876 | View Plating System,Reduce Fracture Plating System,Bone ScrewSummary page 4…dicate device Predicate Device 510(k) Number Manufacturer Primary Predicate EDGE Orthopaedics VIEW and REDUCE Plating Systems K140876 ORTHOFIX SRL Reference device Orthopaedics REDUCE Fracture Plating System Line Extension K142135… | 2014 |
| † | K142135 | Reduce Fracture Plating System Line Extension | 2014 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K140876.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with Rival locking and non-locking bone screws. Plates and screws are intended for single use only. Screws are not intended for use in the spine. Examples of these…
Read the full statement (216 words)
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with Rival locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Examples of these procedures for which the RIVAL™ View Plating Systems™ may be used, but are not limited to:
» First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
» First metatarsal fracture fixation
* Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
» Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux rigidus and/or hallux valgus
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty Implant
Calcaneal-Cuboid Fusion
» Talonavicular Fusion
* Evans Osteotomy
Example of indications for which the RIVAL™ Reduce Plating Systems™ may be used, but are not limited to:
* Metatarsal or metacarpal fractures and osteotomies
* Phalanges fractures and osteotomies
* Lapidus Fusion
» Lisfranc Arthrodesis
* 1st MPJ Arthrodesis
» Forefoot osteotomies
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/K190388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190388: RIVAL View Plating Systems and Reduce Fracture Plating Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190388
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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