Cleared Traditional

K193468 - Tritium Sternal Cable Plate System

K193468 is an FDA 510(k) clearance for Tritium Sternal Cable Plate 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 87-day FDA review.

K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
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Mar 2020
Decision
87d
Days
Class 2
Risk

K193468 is an FDA 510(k) clearance for the Tritium Sternal Cable Plate 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 March 12, 2020 after a review of 87 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 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) devices

FDA 510(k) Submission Details - K193468

510(k) Number K193468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date March 12, 2020
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 Consultant

A & E Medical Corporation
Peter Browne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDQ Cerclage, Fixation

All 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K193468.
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
Sternal Cable System
K193479 · A & E Medical Corporation · Mar 2020
Thorecon Rigid Fixation System
K181607 · A & E Medical Corporation · Oct 2018
Impress SFS System
K173910 · Cable Fix Medical, LLC · Sep 2018
SuperCable® Iso-Elastic™ Cerclage System
K181749 · Kinamed, Incorporated · Aug 2018