Cleared Traditional

K181607 - Thorecon Rigid Fixation System

K181607 is the FDA 510(k) clearance for Thorecon Rigid Fixation System by A & E Medical Corporation. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K181607 · A & E Medical Corporation · Orthopedic device
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Oct 2018
Decision
115d
Days
Class 2
Risk

K181607 is an FDA 510(k) clearance for the Thorecon Rigid Fixation System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by A & E Medical Corporation (Farmingdale, US). The FDA issued a Cleared decision on October 12, 2018 after a review of 115 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 A & E Medical Corporation devices

Submission Details

510(k) Number K181607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2018
Decision Date October 12, 2018
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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

Rti Surgical, Inc.
Sarah Pleaugh

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 82
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K181607.
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SuperCable® Iso-Elastic™ Cerclage System
K181749 · Kinamed, Incorporated · Aug 2018
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
K172975 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Jun 2018