Identifiers
- 510(k) Number
- K172096 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fraxis is a Suture Anchor (Product Code: GEX) designed for use in orthopaedic and plastic surgery procedures. These devices are intended to secure soft tissue to bone, providing stable fixation for tendons, ligaments, or other anatomical structures during reconstructive or repair surgeries.
The device is supplied as a sterile, single-use product and is intended for use in surgical settings. It is classified under the FDA’s Special 510(k) pathway with a clearance type designated as Substantially Equivalent (SESE). No MRI safety classification or reusable specifications are noted in the regulatory submission.
Frequently asked questions
What types of surgical procedures is the Fraxis Suture Anchor intended for, and why is it specifically designed for these uses?
The Fraxis Suture Anchor is designed for orthopaedic and plastic surgery procedures, specifically to secure soft tissue (such as tendons or ligaments) to bone. Its purpose is to provide stable fixation during reconstructive or repair surgeries, ensuring secure attachment of anatomical structures. The device’s design aligns with its intended use in these specialized fields where precise fixation is critical.
Is the Fraxis Suture Anchor reusable, or is it meant for single-use only? How does this affect its use in surgery?
The Fraxis Suture Anchor is explicitly supplied as a sterile, single-use product, meaning it is intended for one surgical procedure only. This design ensures patient safety by eliminating the risk of cross-contamination or degradation from repeated use, which is particularly important in sterile surgical environments where reliability and sterility are paramount.
What does the FDA’s clearance type (Substantially Equivalent, SESE) mean for the Fraxis Suture Anchor, and how does it impact its use in clinical settings?
The FDA’s Substantially Equivalent (SESE) clearance under the Special 510(k) pathway means the Fraxis Suture Anchor has been determined to have the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. Clinically, this indicates that the device has undergone rigorous review to confirm it meets established standards for orthopaedic and plastic surgery applications, providing confidence in its performance and safety for surgeons.
How should the Fraxis Suture Anchor be stored, and what precautions should be taken to maintain its sterility before use?
Since the Fraxis Suture Anchor is a sterile, single-use device, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to preserve sterility, so it should remain intact until immediately before use. Proper storage ensures the device remains uncontaminated and ready for surgical application.
What does the advisory committee designation “General, Plastic Surgery” indicate about the Fraxis Suture Anchor’s regulatory review process?
The advisory committee designation “General, Plastic Surgery” reflects that the Fraxis Suture Anchor’s regulatory submission was reviewed by the Orthopaedic and Rehabilitation Devices Advisory Committee (SU) under the FDA’s Special 510(k) pathway. This indicates the device was evaluated within the context of plastic surgery applications, ensuring its design and intended use align with established clinical practices in that specialty.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172096 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ilooda.co., Ltd
- FDA Applicant
- Ilooda Co,., Ltd.
Sources (1)
- FDA 510(k) K172096 24 fields · synced Sep 19, 2026