Cleared Traditional

Anjon Bremer Halo System (K193256) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193256 · Anjon Holdings, LLC · Orthopedic device
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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

Submission Details

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.

Device Classification

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 84
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K193256.
SteriTrak
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PIP Fix
K181192 · Hand Biomechanics Lab, Inc. · Oct 2018
Anjon Bremer Halo System
K171863 · Anjon Holdings, LLC · Mar 2018
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476 · Synthes (Usa) · Aug 2007
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · Howmedica Osteonics Corp. · Jul 2003