SBI Carpal Fusion Plate
by Small Bone Innovations, Inc.
510(k) K062903
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062903 | Date20 Oct 2006 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SBI Carpal Fusion Plate is a fixation device designed for internal stabilization of carpal bone fusions in the wrist, specifically targeting the capitate, hamate, lunate, and triquetrum. Classified as a bone fixation plate, it is intended to provide rigid support during the healing process of arthrodesis procedures in the carpal bones. Its structure is engineered to maintain proper alignment and promote bony union while minimizing motion at the fusion site.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K062903) as a Class II orthopedic device, falling under product code HRS and reviewed by the Orthopedic Advisory Committee. Storage conditions require protection from moisture and physical damage, and it must be handled with sterile technique prior to implantation. No MRI safety information is specified, and its use is restricted to surgical settings by trained orthopedic professionals.
Other devices from Small Bone Innovations, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the SBI Carpal Fusion Plate used for?
The SBI Carpal Fusion Plate is designed specifically for internal stabilization of carpal bone fusions in the wrist, particularly involving the capitate, hamate, lunate, and triquetrum. It provides rigid support during arthrodesis procedures to maintain proper alignment and promote bony union while minimizing motion at the fusion site, ensuring optimal healing conditions for these carpal bones.
How is the SBI Carpal Fusion Plate supplied and prepared for use?
The device is supplied sterile and intended for single-use only. Prior to implantation, it must be handled using sterile technique to prevent contamination. The packaging protects it from moisture and physical damage, so ensure it remains unopened and undamaged until ready for surgical use.
Can the SBI Carpal Fusion Plate be reused after a single surgical procedure?
No, the SBI Carpal Fusion Plate is explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and the structural integrity required for safe and effective fixation during carpal fusion procedures.
What storage conditions are required for the SBI Carpal Fusion Plate?
The device must be stored in a way that protects it from moisture and physical damage. It should be kept in its original packaging until ready for use, and handled with sterile technique to maintain its sterile field. Proper storage ensures the plate remains intact and ready for surgical implementation.
Is MRI safety information provided for the SBI Carpal Fusion Plate?
No MRI safety information is specified for the SBI Carpal Fusion Plate. This means its compatibility with MRI machines is not documented, and its use in or near MRI environments should be approached with caution. Always consult with radiology staff before proceeding with any MRI-related procedures involving this device.