510(k) · Cleared
ClearedEPIC Extremity Fusion 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 13, 2019 as substantially equivalent to K172441 (Epic Extremity, LLC, 2017) and 3 other predicates after a 107-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Feb 13, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K010612 (2001). 114 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 9 generations between
- 3 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 2 generations backK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
- This deviceK182991 EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019
Show all 13 generations
- Root · 13 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 12 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 11 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 10 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 9 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 8 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 7 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 6 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 5 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 4 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 3 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 2 generations backK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
- This deviceK182991 EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −12 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −11 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −10 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −9 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −8 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −7 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −6 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −5 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −3 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| −2 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| −1 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | 2017 | — |
| 0 (this device) | K182991 | EPIC Extremity Fusion Plate System | Epic Extremity, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 12 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K172441 | EPIC Extremity Fracture Plate SystemSummary page 4…accessories (per 21 CFR 888.3030) - Class II Product Code/Panel: HRS/Orthopedics Predicate Devices: EPIC Extremity Fracture Plate System (K172441) EPIC Extremity Cannulated Screw System (K153333) Ortholoc 3DI Ankle… | 2017 |
| * | K153333 | Epic Extremity Cannulated Screw SystemSummary page 4…HRS/Orthopedics Predicate Devices: EPIC Extremity Fracture Plate System (K172441) EPIC Extremity Cannulated Screw System (K153333) Ortholoc 3DI Ankle Fusion Plating System (K121425) Reference Ortholo… | 2016 |
| * | K121425 | Ortholoc 3DI Ankle Fusion Plating SystemSummary page 4…e System (K172441) EPIC Extremity Cannulated Screw System (K153333) Ortholoc 3DI Ankle Fusion Plating System (K121425) Reference Ortholoc 3DI Ankle Fusion Plating System Line Extension (K… | 2012 |
| * | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionSummary page 4…3DI Ankle Fusion Plating System (K121425) Reference Ortholoc 3DI Ankle Fusion Plating System Line Extension (K163650) Reference Indications for Use: The EPIC Extremity Fusion Plate System is indicated for use in stabilization of fresh fractures,… | 2017 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 24 of the 114 ancestors have a recall of any class.
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?
The EPIC Extremity Fusion Plate System is indicated for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. 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/K182991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182991: EPIC Extremity Fusion Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182991
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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