SuperCable® Iso-Elastic Cerclage System
FDA 510(k) K181749 · Kinamed, Incorporated
510(k) numberK181749
Submission
- Device name
- SuperCable® Iso-Elastic Cerclage System
- Applicant
- Kinamed, Incorporated
Camarillo, CA, US - Received
- July 2, 2018
- Decision date
- August 1, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/14/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | Riverpoint Medical, LLC | 07/26/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
More from Neos Surgery S.L
| 510(k) | Device | Decision |
|---|---|---|
| K122049 | Neuropro Low Profile Cranial Plating SystemGWO · Traditional | 04/05/2013SE |
| K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)JDQ · Special | 01/12/2011SE |
| K072250 | Supercable Grip and Plate SystemKTT · Traditional | 11/09/2007SE |
| K050897 | Navipro Shoulder Software ModuleHAW · Traditional | 05/24/2005SE |
| K033668 | Navipro Knee Software ModuleHAW · Traditional | 03/11/2004SE |
| K032950 | Gem Inset Patellar ComponentJWH · Traditional | 12/19/2003SE |
| K030256 | Iso-Elastic Cerclage SystemJDQ · Traditional | 10/21/2003SE |
| K020764 | NaviproHAW · Traditional | 06/03/2002SE |
| K013982 | Kinematch Patello-Femoral Resurfacing ImpalantKRR · Traditional | 05/21/2002SE |
| K010101 | Gem Posterior Stabilized Total Knee SystemJWH · Traditional | 05/17/2001SE |
Questions and answers
When was SuperCable® Iso-Elastic Cerclage System cleared by the FDA?
SuperCable® Iso-Elastic Cerclage System (K181749) received a 510(k) decision of Substantially Equivalent on August 1, 2018, 30 days after the submission was received.
What is the product code of K181749?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.