510(k) · Cleared
Recalled · Class II · 2018View Plating System,Reduce Fracture Plating System,Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic · HRS Plate, Fixation, Bone
Cleared on Jul 22, 2014 as substantially equivalent to K061808 (Darco International, Inc., 2006) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it. It has been recalled 15 times.
- Decided
- Jul 22, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 15
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022325 (2002). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
- 1 generation backK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
- This deviceK140876 View Plating System,Reduce Fracture Plating System,Bone ScrewIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic · 2014
- Descendant · cites it directly · 0 of its ownK190388 RIVAL View Plating Systems and Reduce Fracture Plating SystemsOrthofix Srl · 2019
- Descendant · cites it directly · 0 of its ownK142135 Reduce Fracture Plating System Line ExtensionIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic · 2014 · Recalled
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 |
|---|---|---|---|---|---|
| −2 | K022325 | Normed Titanium Osteotomy Plating System | Osteomedics, Inc. | 2002 | 1 |
| −1 | K061808 | Darco Locking Bone Plate System | Darco International, Inc. | 2006 | 3 |
| 0 (this device) | K140876 | View Plating System,Reduce Fracture Plating System,Bone Screw | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014 | — |
| +1 | K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems | Orthofix Srl | 2019 | — |
| +1 | K142135 | Reduce Fracture Plating System Line Extension | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…Product Code: HRS/HWC Panel Code: Orthopedics Predicate Device [21 CFR 807.92(a)(3)] DARCO Locking Plating System - K061808 (Darco International) ORTHOLOC® 2.0/2.4 Plate System - K090692 (Wright Medical Technology) Descriptio… | 2006 |
| * | K090692 | Ortholoc 2.0/2.4 Plate SystemSummary page 1…1 CFR 807.92(a)(3)] DARCO Locking Plating System - K061808 (Darco International) ORTHOLOC® 2.0/2.4 Plate System - K090692 (Wright Medical Technology) Description of the Device [21 CFR 807.92(a)(4)] The EDGE Orthopaedics' VIEWTM Plating System has bee… | 2009 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2018 | Class II | Z-2130-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2126-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2124-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2132-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2122-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2131-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2123-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2119-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2120-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2127-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2121-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2133-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2135-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2134-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
| Apr 6, 2018 | Class II | Z-2129-2018 | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K190388 (Orthofix Srl, 2019) has gone furthest, with 0 descendants of its own.
- 23 other devices also cite its predicate K061808.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
EDGE Orthopaedics' VIEW and REDUCE Plating Systems 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 EDGE Orthopaedics locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140876: View Plating System,Reduce Fracture Plating System,Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140876
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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