Cleared Traditional

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System (K153242) - FDA 510(k) Clearance

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

K153242 · Frontier Medical Devices, Inc. · Orthopedic device
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Jan 2016
Decision
65d
Days
Class 2
Risk

K153242 is an FDA 510(k) clearance for the Frontier Medical Devices In-Line Orthopedic Cable Cerclage System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Frontier Medical Devices, Inc. (Gwinn, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Frontier Medical Devices, Inc. devices

Submission Details

510(k) Number K153242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date January 13, 2016
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 122d · This submission: 65d
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 50
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K153242.
Thorecon™ Fixation System
K173579 · A & E Medical Corporation · Feb 2018
Arthrex FiberTape Cerclage
K170206 · Arthrex, Inc. · Nov 2017
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
K151848 · Zimmer, Inc. · Jan 2016
Suture Wires and Wire Loops
K150889 · Zimmer, Inc. · Jul 2015
PERI-PROSTHETIC CABLE SYSTEM
K133354 · Biomet, Inc. · Jan 2014
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011