Cleared Traditional

Tritium Sternal Cable Plate System (K193468) - FDA 510(k) Clearance

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

K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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 128
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K193468.
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VariTrax Sternal CircumFixation System
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