Thorecon Rigid Fixation System

FDA 510(k) K181607 · A & E Medical Corporation

Substantially Equivalent

510(k) numberK181607

Submission

Device name
Thorecon Rigid Fixation System
Applicant
A & E Medical Corporation
Farmingdale, NJ, US
Received
June 19, 2018
Decision date
October 12, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDQ – Cerclage, Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3010
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code JDQ

510(k)DeviceApplicantDecision
K261271Cable-Ready® Cable Grip SystemJDQ · Traditional Pioneer Surgical Technology, Inc.07/16/2026SE
K243905Stitch Cerclage – Suture TapesJDQ · Traditional GM Dos Reis Industria e Comercio Ltda.08/14/2025SE
K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional Arthrex, Inc.02/20/2025SE
K232733Mbrace CableJDQ · Traditional Medacta International S.A.05/03/2024SE
K233949ACCORD Cable SystemJDQ · Traditional Smith & Nephew, Inc.03/13/2024SE
K232986VariTrax Sternal CircumFixation SystemJDQ · Traditional Circumfix Solutions, Inc.01/30/2024SE
K230976Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional Arthrex, Inc.08/24/2023SE
K231333STRETTO™ Cable SystemJDQ · Traditional Globus Medical, Inc.08/04/2023SE
K220765HS Fiber CerclageJDQ · Traditional Riverpoint Medical, LLC07/26/2023SE
K221795STERN FIX Sternal Stabilization SystemJDQ · Traditional Neos Surgery S.L10/19/2022SE

More from Neos Surgery S.L

510(k)DeviceDecision
K193479Sternal Cable SystemJDQ · Traditional 03/23/2020SE
K180582Sternal Cable SystemJDQ · Traditional 05/31/2018SE
K173579Thorecon™ Fixation SystemJDQ · Traditional 02/12/2018SE

Questions and answers

When was Thorecon Rigid Fixation System cleared by the FDA?

Thorecon Rigid Fixation System (K181607) received a 510(k) decision of Substantially Equivalent on October 12, 2018, 115 days after the submission was received.

What is the product code of K181607?

The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.