ICONN Revolution Knotless Suture Anchor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182264 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ICONN Revolution Knotless Suture Anchor is a knotless soft-tissue fixation device designed for securing tendons, ligaments, or other soft tissues to bone. It belongs to the category of suture anchors, which are used to stabilize soft tissue to cortical bone without the need for traditional knot tying, reducing the risk of suture cut-through and improving biomechanical strength. This device is intended for orthopedic applications where secure, durable fixation is required, such as in rotator cuff repairs or labral reconstructions.
The anchor is supplied sterile and intended for single-use, adhering to standard orthopedic surgical protocols. It is compatible with MRI environments, as specified in its design, and is available in modular configurations to accommodate various suture or tape setups. Storage requires adherence to sterile packaging guidelines, and its regulatory clearance under the FDA 510(k) process (K182264) confirms its compliance with orthopedic implant standards. The device is manufactured by ICONN Orthopedics, LLC, and distributed for use in surgical settings where soft-tissue-to-bone fixation is required.
Frequently asked questions
What is the ICONN Revolution Knotless Suture Anchor used for?
The ICONN Revolution Knotless Suture Anchor is designed for securing tendons, ligaments, or other soft tissues to bone in orthopedic surgeries. It eliminates the need for traditional knot tying, which reduces the risk of suture cut-through and enhances fixation strength. Common applications include rotator cuff repairs and labral reconstructions, where stable and durable soft-tissue-to-bone attachment is critical.
How is the ICONN Revolution Knotless Suture Anchor supplied and prepared for use?
The device is supplied sterile in its original packaging, adhering to standard orthopedic surgical protocols. It is intended for single-use only, meaning each anchor should be used once and then discarded. Before use, ensure the sterile barrier remains intact and follow the manufacturer’s instructions for proper handling and preparation.
Is the ICONN Revolution Knotless Suture Anchor compatible with MRI imaging?
Yes, the ICONN Revolution Knotless Suture Anchor is explicitly designed to be MRI-compatible. This feature allows for postoperative imaging without interference, which is particularly useful in orthopedic cases where follow-up scans are necessary to monitor healing progress.
What modular configurations are available for the ICONN Revolution Knotless Suture Anchor?
The device is available in modular configurations to accommodate various suture or tape setups. This flexibility ensures compatibility with different surgical techniques and patient anatomies, allowing clinicians to choose the appropriate setup for their specific procedure.
How should the ICONN Revolution Knotless Suture Anchor be stored?
Storage must adhere to sterile packaging guidelines to maintain its sterility. The anchor should be kept in its original, unopened packaging until immediately before use. Avoid exposure to moisture, extreme temperatures, or contamination, as these factors could compromise the device’s integrity and sterility.
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. Sources consulted: ICONN Revolution Knotless Suture Anchor, ICONN Orthopedics | Value-Driven Orthopedic Implants, ICONN Revolution Knotless Suture Anchor (K182264) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182264 | Class II | Active |
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Manufacturer
- Manufacturer
- Iconn Orthopedics, Llc
Sources (1)
- FDA 510(k) K182264 24 fields · synced Oct 1, 2026