RibFix Blu Thoracic Fixation System
by Biomet Microfixation 3 variants
510(k) K151173
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151173 | Date26 May 2015 | 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- Withdrawn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
- Biomet Microfixation RibFix Blu Thoracic Fixation System
- 510(k) Number
- FDA Product Code
- HWC
- 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 RibFix Blu Thoracic Fixation System is a medical device classified as a thoracic fixation system for stabilising and rigidly fixing fractures in the chest wall, including sternal reconstructive procedures, trauma-related injuries, or planned osteotomies. It is designed to promote bone union in both normal and poor-quality bone environments, providing structural support to facilitate healing.
This system is supplied as a reusable surgical instrument set, intended for use in orthopedic procedures under sterile conditions. The plates are engineered to conform to the natural curvature of ribs, ensuring stability while accommodating the physiological movement of the chest wall. The device is authorised under FDA 510K clearance (K151173) and is intended for single-patient use per procedure. Storage and handling must adhere to standard surgical instrument protocols to maintain sterility and functionality.
Other devices from Biomet Microfixation
Questions
AI-generated answers, 1 Oct 2026
What is the RibFix Blu Thoracic Fixation System used for?
The RibFix Blu Thoracic Fixation System is designed to stabilize and rigidly fix fractures in the chest wall, including sternal reconstructive procedures, trauma-related rib injuries, or planned osteotomies. Its plates conform to the natural curvature of ribs, providing structural support to facilitate bone union in both normal and poor-quality bone environments, ensuring stability while accommodating the physiological movement of the chest.
Is the RibFix Blu Thoracic Fixation System reusable or single-use?
The RibFix Blu Thoracic Fixation System is supplied as a reusable surgical instrument set. However, the plates themselves are intended for single-patient use per procedure. This distinction ensures sterility and functionality are maintained according to standard surgical instrument protocols, preventing cross-contamination between patients.
How should the RibFix Blu Thoracic Fixation System be stored?
The system must be stored and handled following standard surgical instrument protocols to preserve sterility and functionality. Since it is a reusable set, proper cleaning, disinfection, and packaging are critical to maintain its performance for subsequent procedures. Always adhere to manufacturer guidelines for storage to ensure the device remains ready for use when needed.
Does the RibFix Blu Thoracic Fixation System require special handling for sterility?
Yes, the RibFix Blu Thoracic Fixation System is intended for use under sterile conditions. As a reusable surgical instrument set, it must be thoroughly cleaned, disinfected, and sterilized between uses to prevent contamination. The plates, while designed for single-patient use per procedure, rely on the overall system’s sterility protocols to ensure safe and effective performance during surgery.
What regulatory clearance does the RibFix Blu Thoracic Fixation System hold?
The RibFix Blu Thoracic Fixation System holds FDA 510K clearance under the reference number K151173. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a thoracic fixation system, ensuring it can be legally marketed and used in the United States for its intended purposes.