Cleared Traditional

K193256 - Anjon Bremer Halo System

K193256 is an FDA 510(k) clearance for Anjon Bremer Halo System, manufactured by Anjon Holdings, LLC. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K193256 · Anjon Holdings, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
97d
Days
Class 2
Risk

K193256 is an FDA 510(k) clearance for the Anjon Bremer Halo System. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Anjon Holdings, LLC (Jacksonville, US). The FDA issued a Cleared decision on March 2, 2020 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Anjon Holdings, LLC devices

FDA 510(k) Submission Details - K193256

510(k) Number K193256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2019
Decision Date March 02, 2020
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JEC Component, Traction, Invasive

All 53
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K193256.
SteriTrak
K203605 · Arbutus Medical, Inc. · Apr 2021
DigiFix Sterile Kit
K192465 · Virak Orthopedics, LLC · Oct 2019
PIP Fix
K181192 · Hand Biomechanics Lab, Inc. · Oct 2018
Anjon Bremer Halo System
K171863 · Anjon Holdings, LLC · Mar 2018
Medline ReNewal Reprocessed Stryker External Fixation Devices
K163028 · Surgical Instrument Service and Savings, Inc. · Dec 2016
DIGIFIX EXTERNAL FIXATION SYSTEM
K132731 · Virak Orthopedic Research, LLC · Jan 2014