SuperCable Iso-Elastic Cerclage System
510(k) K181749
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181749 | Date1 Aug 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The SuperCable Iso-Elastic Cerclage System is a polymer-based orthopedic device classified as a cerclage device (Product Code: JDQ). It is designed to provide internal fixation for bone fractures by maintaining reduction through tensioned loops around bone fragments. The system combines a flexible, high-strength cable with a metal clasp to secure and stabilize bone segments during the healing process.
The device consists of a braided cerclage cable made from ultra-high-molecular-weight polyethylene (UHMWPE) strands over a nylon core, paired with titanium alloy clasp components. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K181749) as substantially equivalent to existing orthopedic cerclage systems. Storage and handling follow manufacturer guidelines to preserve sterility and structural integrity.
Other devices from Kinamed, Incorporated
Questions
AI-generated answers, 20 Sep 2026
What types of bone fractures is the SuperCable Iso-Elastic Cerclage System designed to stabilize, and how does it work?
The SuperCable Iso-Elastic Cerclage System is designed for internal fixation of bone fractures by maintaining reduction through tensioned loops around bone fragments. It uses a flexible, high-strength ultra-high-molecular-weight polyethylene (UHMWPE) cable with a nylon core, paired with titanium alloy clasps, to secure and stabilize bone segments during healing. The system applies controlled tension to keep fractured bone pieces aligned, promoting proper healing without rigid external fixation.
Is the SuperCable Iso-Elastic Cerclage System reusable, or is it intended for single-use only?
The SuperCable Iso-Elastic Cerclage System is sterile and intended for single-use only. This design choice ensures patient safety by preventing cross-contamination and maintaining the integrity of the polymer and metal components, which could degrade with reuse. Always follow the manufacturer’s storage and handling guidelines to preserve sterility.
What materials are used in the SuperCable Iso-Elastic Cerclage System, and why is this combination important?
The system combines a braided UHMWPE cable (for flexibility and high tensile strength) over a nylon core with titanium alloy clasps. UHMWPE provides durability and resistance to wear, while the nylon core enhances structural stability. The titanium clasps offer secure, corrosion-resistant fixation points, ensuring long-term stability for bone fragments during healing.
How should the SuperCable Iso-Elastic Cerclage System be stored to maintain its sterility and performance?
The system must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. Since it is supplied sterile and single-use, it should remain in its original packaging until use, protected from moisture, heat, and physical damage. Avoid exposure to chemicals or contaminants that could compromise the polymer or metal components before implantation.
What regulatory pathway does the SuperCable Iso-Elastic Cerclage System follow, and how does this affect its use?
The SuperCable Iso-Elastic Cerclage System is regulated under the FDA 510(k) clearance process (K181749) and is classified as substantially equivalent to existing orthopedic cerclage systems. This means it meets FDA standards for safety and effectiveness as determined through a pre-market review. Clinicians and buyers can rely on this clearance to confirm the device’s compliance with U.S. regulatory requirements for orthopedic fixation devices.