Fastin RC Anchor
510(k) K983818
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983818 | Date23 Nov 1998 | 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- Withdrawn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
- Mitek Fastin Rc Anchor
- 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 Fastin RC Anchor is an orthopedic device classified as a suture anchor (product code MBI) designed for securing USP #2 suture to bone. It provides a mechanical fixation point for soft tissue attachment, facilitating surgical repairs in musculoskeletal procedures. The device is intended for use in arthroscopic and open surgical techniques where stable fixation is required. Its threaded design ensures secure engagement with cortical bone, enabling reliable suture retention.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K983818) with a Special classification under the Orthopedic Advisory Committee. The Fastin RC Anchor is compatible with MRI environments, though specific safety parameters should be confirmed with imaging protocols. Storage requires adherence to sterile packaging instructions, and it is distributed by Mitek Products, Westwood, MA.
Other devices from Mitek Products
Questions
AI-generated answers, 1 Oct 2026
What is the Fastin RC Anchor used for in surgical procedures?
The Fastin RC Anchor is designed to secure USP #2 suture to bone, providing a mechanical fixation point for soft tissue attachment. It is specifically intended for use in musculoskeletal procedures where stable fixation is required, such as arthroscopic or open surgeries. The threaded design ensures secure engagement with cortical bone, making it ideal for reliable suture retention during repairs.
How is the Fastin RC Anchor supplied and is it reusable?
The Fastin RC Anchor is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining device integrity. Reuse is not recommended due to potential degradation of performance and sterility risks.
What storage instructions should be followed for the Fastin RC Anchor?
The Fastin RC Anchor must be stored according to the sterile packaging instructions provided by Mitek Products. Proper storage ensures the device remains uncontaminated and ready for use. Always check the packaging for any specific environmental conditions, such as temperature or humidity, to maintain sterility.
Is the Fastin RC Anchor compatible with MRI environments?
Yes, the Fastin RC Anchor is designed to be compatible with MRI environments. However, it is important to confirm specific safety parameters with the imaging protocols in use, as MRI settings can vary between facilities. This ensures optimal performance and patient safety during imaging.
What regulatory clearance does the Fastin RC Anchor hold?
The Fastin RC Anchor holds FDA 510(k) clearance under the reference number K983818. It is classified under the Orthopedic Advisory Committee with a Special classification, indicating it is deemed substantially equivalent to a predicate device. This clearance allows it to be marketed for its intended use in securing suture to bone.