Bfix Orthopedic External Fixator Systems
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200491 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bfix Orthopedic External Fixator Systems are classified as single/multiple component metallic bone fixation devices under 21 CFR 888.3030. These systems provide external stabilization for bone fractures or deformities by securing pins and clamps to an external fixation frame, facilitating controlled alignment and healing of skeletal structures.
The systems are designed for use in orthopedic settings and are supplied as reusable medical devices. They are regulated under FDA 510(k) clearance (K200491) and the European Medical Device Directive (MDD). The Bfix systems are intended for surgical application by trained professionals and must be handled according to sterile procedures. No specific MRI safety or single-use designation is noted in the provided data.
Frequently asked questions
Are the Bfix Orthopedic External Fixator Systems intended for single-use or can they be reused after sterilization?
The Bfix Orthopedic External Fixator Systems are explicitly labeled as reusable medical devices in the provided data. Since they are metallic and designed for surgical use, they must be properly sterilized between uses to maintain safety and functionality. Always follow manufacturer guidelines for sterilization and handling to ensure compliance with sterile procedures.
What types of bone conditions or injuries are these fixators primarily used to stabilize?
The Bfix Orthopedic External Fixator Systems are designed to provide external stabilization for bone fractures or deformities. They work by securing pins and clamps to an external fixation frame, allowing controlled alignment and support during the healing process of skeletal structures. These systems are intended for orthopedic applications where internal fixation may not be feasible or sufficient.
How are these fixators supplied, and do they come in different sizes or models?
The data does not specify exact sizes or models, but the Bfix Orthopedic External Fixator Systems are supplied as reusable metallic devices in multiple component configurations (as indicated by the product code KTT, which aligns with external fixation systems). While the exact variations (e.g., frame sizes, pin lengths) are not detailed, the systems are modular, allowing for customization based on clinical needs. For precise sizing or model options, refer to the manufacturer’s catalog or technical specifications.
Do these fixators require any special handling or storage conditions?
Since the Bfix systems are reusable and metallic, they should be stored in a clean, dry environment to prevent corrosion or contamination. While no specific storage instructions are provided, proper maintenance—including cleaning and sterilization—is critical before reuse. Always follow the manufacturer’s guidelines for handling to ensure longevity and safety, particularly in surgical settings where sterility is paramount.
What regulatory pathways have these fixators undergone, and how does that affect their use?
The Bfix Orthopedic External Fixator Systems have undergone FDA 510(k) clearance (K200491) and compliance with the European Medical Device Directive (MDD). This means they are considered substantially equivalent to predicate devices under FDA regulations and meet EU safety and performance standards. Clinicians and buyers should confirm local regulatory compliance before use, but these clearances indicate the systems meet established requirements for external fixation devices in their respective markets.
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: Bfix Orthopedic External Fixator Systems (K200491) — FDA 510 (k ..., K200491 FDA 510(k) - Bfix Orthopedic External Fixator Systems, PDF Aike (Shanghai) Medical Instrument Co., Ltd. Hongying Gu QC Manager ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200491 | Class II | Active |
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Manufacturer
- Manufacturer
- Aike (Shanghai) Medical Instrument Co., Ltd
- FDA Applicant
- Aike (Shanghai) Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K200491 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026