510(k) Report

FDA applicant

Epic Extremity, LLC

Cranberry Twp, PA5 decisions2016–20192 recalls

FDA records 5 decisions for Epic Extremity, LLC (Cranberry Twp, PA) from 2016 to 2019: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Epic Extremity, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 22017: 22019: 1
2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2018

2018: 2
2016high 2 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Epic Extremity, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Epic Extremity, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone3decisions
  • HWCScrew, Fixation, Bone2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 122 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153340Epic Extremity Plate SystemEpic Extremity, LLC · 20162cite it
  • K172441EPIC Extremity Fracture Plate SystemEpic Extremity, LLC · 20171cites it
  • K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC · 20161cites it

What has FDA decided for it lately?

  • K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC · 2019
  • K172441EPIC Extremity Fracture Plate SystemEpic Extremity, LLC · 2017
  • K163038EPIC Extremity Snap-Off ScrewEpic Extremity, LLC · 2017
  • K153340Epic Extremity Plate SystemEpic Extremity, LLC · 20162 recalls
  • K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC · 2016

All 5 as Epic Extremity, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K153340Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended…Mar 20, 2018Class II
  • K153340Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm…Mar 20, 2018Class II

Other applicant names beginning “Epic”

FDA records each applicant name separately; these may or may not be the same firm.

Epic Medical Pte., Ltd. 22Epic Medical Equipment Services, Inc. 13Epic Systems, Inc. 4Epic Extremely, LLC 1Epic Medical Concepts & Innovations 1