Cleared Traditional

K150581 - Tritium Sternal Cable Plate System

K150581 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.

K150581 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
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Jun 2015
Decision
87d
Days
Class 2
Risk

K150581 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 June 4, 2015 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 - K150581

510(k) Number K150581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2015
Decision Date June 04, 2015
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 Peers - JDQ Cerclage, Fixation

All 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K150581.
DSM Biomedical DPR Cable
K143716 · Dsm Biomedical · Oct 2015
Frontier Medical Devices Posterior Cable Screw System
K151346 · Frontier Medical Devices, Inc. · Aug 2015
Suture Wires and Wire Loops
K150889 · Zimmer, Inc. · Jul 2015
PERI-PROSTHETIC CABLE SYSTEM
K133354 · Biomet, Inc. · Jan 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · Pioneer Surgical Technology, Inc. · Jan 2014
COMPRESSYN BAND
K130431 · Dallen Medical, Inc. · Jul 2013