510(k) · Cleared
Recalled · Class II · 2018Epic Extremity Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Extremity, LLC · HRS Plate, Fixation, Bone
Cleared on Feb 9, 2016 as substantially equivalent to K061808 (Darco International, Inc., 2006) after an 82-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 9, 2016
- Review
- 82 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022325 (2002). 3 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 deviceK153340 Epic Extremity Plate SystemEpic Extremity, LLC · 2016
- Descendant · cites it directly · 1 of its ownK172441 EPIC Extremity Fracture Plate SystemEpic Extremity, LLC · 2017
- Descendant · cites it directly · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK182991 EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K172441EPIC Extremity Fracture Plate SystemEpic Extremity, LLC · 2017 · cites it directly1descendant
- K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · cites it directly0descendants
- K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019 · 2 generations on0descendants
View 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) | K153340 | Epic Extremity Plate System | Epic Extremity, LLC | 2016 | — |
| +1 | K172441 | EPIC Extremity Fracture Plate System | Epic Extremity, LLC | 2017 | — |
| +1 | K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | 2023 | — |
| +2 | K182991 | EPIC Extremity Fusion Plate System | Epic Extremity, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 4…and accessories (per 21 CFR 888.3030) Product Code/Panel: HRS/Orthopedics Predicate Devices: DARCO Locking Bone Plate System (K061808). Intended Use: The Epic Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, j… | 2006 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Mar 20, 2018 | Class II | Z-1874-2018 | Error in labeling | There is an error in the caddy artwork that misidentifies a specific plate and screw. |
| Mar 20, 2018 | Class II | Z-1875-2018 | Error in labeling | There is an error in the caddy artwork that misidentifies a specific plate and screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K172441 (Epic Extremity, LLC, 2017) has gone furthest, with 1 descendant 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. 2016, 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 Epic Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients. The plates/screws are intended for single use only.
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/K153340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153340: Epic Extremity Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153340
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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