Cleared Traditional

K170206 - Arthrex FiberTape Cerclage

K170206 is an FDA 510(k) clearance for Arthrex FiberTape Cerclage, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K170206 · Arthrex, Inc. · Orthopedic device
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Nov 2017
Decision
295d
Days
Class 2
Risk

K170206 is an FDA 510(k) clearance for the Arthrex FiberTape Cerclage. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 15, 2017 after a review of 295 days - an extended review 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: 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 Arthrex, Inc. devices

FDA 510(k) Submission Details - K170206

510(k) Number K170206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date November 15, 2017
Days to Decision 295 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
173d slower than avg
Panel avg: 122d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K170206.
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
K172975 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Jun 2018
Sternal Cable System
K180582 · A & E Medical Corporation · May 2018
Thorecon™ Fixation System
K173579 · A & E Medical Corporation · Feb 2018
Tritium® Sternal Cable Plate System
K161876 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Sep 2016
KLS Martin LSS Plating System
K151983 · KLS-Martin L.P. · Apr 2016
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
K151848 · Zimmer, Inc. · Jan 2016