Innovasive ROC EZ Suture Bone Fastener 2.8MM and 3.5MM
510(k) K971922
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971922 | Date7 Aug 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Innovasive 2.8mm and 3.5mm Roc Ez Suture Bone Fastener
- 510(k) Number
- FDA Product Code
- MBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Innovasive ROC EZ Suture Bone Fastener is a Fastener, Fixation, Nondegradable, Soft Tissue device designed for reattaching soft tissue to bone. It consists of two sizes—2.8mm and 3.5mm—intended to provide secure fixation in orthopedic procedures, particularly for shoulder repairs. The system integrates suture loops for enhanced tissue attachment, facilitating stable reattachment during surgical interventions. Its nondegradable construction ensures long-term stability without resorption.
This device is supplied sterile and intended for single-use in controlled surgical environments. It falls under FDA 510(k) clearance (K971922) as a Class II device under the MBI product code, adhering to special controls for soft tissue fixation. No MRI safety or reusable specifications are noted in the regulatory data. Storage should follow manufacturer guidelines for sterile orthopedic implants. The device’s design and clearance are based on substantial equivalence to the Mitek GII Anchor, a predicate device for soft tissue anchoring systems.
Other devices from Innovasive Devices, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Innovasive ROC EZ Suture Bone Fastener used for?
The Innovasive ROC EZ Suture Bone Fastener is designed specifically for reattaching soft tissue to bone during orthopedic procedures, particularly in shoulder repairs. Its suture loops enhance tissue attachment, ensuring stable fixation during surgical interventions. The nondegradable material provides long-term stability without the need for resorption, making it ideal for procedures requiring durable fixation.
How is the Innovasive ROC EZ Suture Bone Fastener supplied and what are its key features?
The device is supplied sterile and intended exclusively for single-use in controlled surgical settings. It comes in two sizes—2.8mm and 3.5mm—to accommodate varying clinical needs. The nondegradable construction ensures prolonged stability, and the integrated suture loops improve tissue attachment, facilitating reliable reattachment during surgery.
Is the Innovasive ROC EZ Suture Bone Fastener reusable or MRI-safe?
The Innovasive ROC EZ Suture Bone Fastener is designed for single-use only, as indicated in the regulatory data. There are no specifications or notes regarding MRI safety for this device, so its use in MRI environments should be confirmed with the manufacturer before application.
What regulatory clearance does the Innovasive ROC EZ Suture Bone Fastener hold?
The Innovasive ROC EZ Suture Bone Fastener holds FDA 510(k) clearance under the product code MBI, classified as a Class II device. The clearance is based on substantial equivalence to the Mitek GII Anchor, a predicate device for soft tissue anchoring systems. This classification ensures it meets regulatory standards for soft tissue fixation.
How should the Innovasive ROC EZ Suture Bone Fastener be stored?
Storage of the Innovasive ROC EZ Suture Bone Fastener should follow the manufacturer’s guidelines for sterile orthopedic implants. Since it is supplied sterile and intended for single-use, proper storage conditions are critical to maintaining sterility and device integrity until use. Always refer to the manufacturer’s instructions for precise storage recommendations.