Cleared Traditional

K193479 - Sternal Cable System

K193479 is the FDA 510(k) clearance for Sternal Cable System by A & E Medical Corporation. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K193479 · A & E Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
98d
Days
Class 2
Risk

K193479 is an FDA 510(k) clearance for the Sternal Cable System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by A & E Medical Corporation (Farmingdale, US). The FDA issued a Cleared decision on March 23, 2020 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 A & E Medical Corporation devices

Submission Details

510(k) Number K193479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date March 23, 2020
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 82
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K193479.
Stern Fix Sternal Stabilization System
K211613 · Neos Surgery S.L · Jan 2022
EVOS Cabling System
K201497 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Oct 2020
Dall-Miles® Cable System
K202016 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2020
Tritium Sternal Cable Plate System
K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Mar 2020
Thorecon Rigid Fixation System
K181607 · A & E Medical Corporation · Oct 2018
Impress SFS System
K173910 · Cable Fix Medical, LLC · Sep 2018