Cleared Traditional

K201497 - EVOS Cabling System

K201497 is an FDA 510(k) clearance for EVOS Cabling System, manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The device is a Class 2 Orthopedic device with 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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K201497

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.

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 130
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K201497.
HS Fiber Cerclage
K220765 · Riverpoint Medical, LLC · Jul 2023
STERN FIX Sternal Stabilization System
K221795 · Neos Surgery S.L · Oct 2022
Stern Fix Sternal Stabilization System
K211613 · Neos Surgery S.L · Jan 2022
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
K201497 · EVOS Cabling System
Download PDF FDA Summary Pioneer Surgical Tech…