FDA applicant

Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic

Boonton, NJ2 decisions2014–201420 recalls

FDA records 2 decisions for Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic (Boonton, NJ) in 2014: 2 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Its devices cite 3 predicates, 1 of them its own earlier devices. 20 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 Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

20in 2018

2014high 20 (2018) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Icon”

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

Icon Medical Systems, Inc. 1 Icon Intl., LLC 1 Icon Wheelchairs, Inc. 1 Icon Orthopaedic Concepts Dba Edge Orthopaedics 1

Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Icon”