Cleared Traditional

K201497 - EVOS Cabling System

K201497 is the FDA 510(k) clearance for EVOS Cabling System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K201497 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
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Oct 2020
Decision
145d
Days
Class 2
Risk

K201497 is an FDA 510(k) clearance for the EVOS Cabling System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on October 28, 2020 after a review of 145 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 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) devices

Submission Details

510(k) Number K201497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date October 28, 2020
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 K201497.
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Dall-Miles® Cable System
K202016 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2020
Sternal Cable System
K193479 · A & E Medical Corporation · Mar 2020
Tritium Sternal Cable Plate System
K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Mar 2020