510(k) · Cleared
Recalled · Class II · 2018Reduce Fracture Plating System Line Extension
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 Aug 28, 2014 as substantially equivalent to K140876 (Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic, 2014) after a 24-day review. Its family tree reaches back 3 generations to 2002. It has been recalled 5 times.
- Decided
- Aug 28, 2014
- Review
- 24 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 5
- 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 deviceK142135 Reduce Fracture Plating System Line ExtensionIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic · 2014
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) | K142135 | Reduce Fracture Plating System Line Extension | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014 | — |
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…, 21 CFR 888.3030, Product Code: HRS Panel Code: Orthopedics Predicate Device [21 CFR 807.92(a)(3)] EDGE Orthopaedics’ VIEW and REDUCE Plating Systems – K140876 Description of the Device [21 CFR 807.92(a)(4)] The EDGE Orthopaedics’ REDUCE® Fracture Plating System Line Extension has been… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2018 | Class II | Z-2117-2018 | 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-2128-2018 | 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-2116-2018 | 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-2125-2018 | 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-2118-2018 | 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. |
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 3.9 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. 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’ REDUCE® Fracture Plating System is 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/K142135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142135: Reduce Fracture Plating System Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142135
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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