510(k) · Cleared
ClearedEpic Extremity Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Extremity, LLC · HWC Screw, Fixation, Bone
Cleared on Jan 19, 2016 as substantially equivalent to K082320 (Wrightmedicaltechnologyinc, 2008) and 1 other predicate after a 61-day review. Its family tree reaches back 3 generations to 1981. 1 later device descends from it.
- Decided
- Jan 19, 2016
- Review
- 61 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810205 (1981). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK810205 Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981
- 2 generations backK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
- 1 generation backK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
- This deviceK153333 Epic Extremity Cannulated Screw SystemEpic Extremity, LLC · 2016
- Descendant · cites it directly · 0 of its ownK182991 EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810205 | Mecron Cancellous Cannulated Bone Screws | Serrano Intl. | 1981 | — |
| −2 | K021233 | Aap Cannulated Screws | Aap Implantate AG | 2002 | — |
| −1 | K080101 | Aap Cannulated Screw and Darco Headed Screw | Aap Implantate AG | 2008 | — |
| 0 (this device) | K153333 | Epic Extremity Cannulated Screw System | Epic Extremity, LLC | 2016 | — |
| +1 | K182991 | EPIC Extremity Fusion Plate System | Epic Extremity, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K082320 | Darco Small ScrewSummary page 4…ener (per 21 CFR 888.3040) – Class II Product Code/Panel: HWC/Orthopedics/87 Predicate Devices: Wright Compression Screws (K082320) aap Cannulated Screw/Darco Headed Screws (K080101) Intended Use: The Epic Extremity Cannulated Scr… | 2008 |
| * | K080101 | Aap Cannulated Screw and Darco Headed ScrewSummary page 4…/Panel: HWC/Orthopedics/87 Predicate Devices: Wright Compression Screws (K082320) aap Cannulated Screw/Darco Headed Screws (K080101) Intended Use: The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis,… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182991 | EPIC Extremity Fusion Plate System | 2019 | 0 |
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 35 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K182991 (Epic Extremity, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K082320.
How does its category compare?
All HWC devicesHWC Screw, 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 · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.
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/K153333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153333: Epic Extremity Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153333
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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