Identifiers
- 510(k) Number
- K242797 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OsteoFlo HydroFiber is a hydrophilic synthetic bone graft (Product Code: MQV) designed as a standalone, moldable, and highly flowable material for filling bone voids. Its fiber-based composition is intended to support bone regeneration while resisting migration under irrigation, making it suitable for spinal applications requiring structural integration.
This device is supplied as a single-use, sterile product and is intended for use in orthopedic procedures, including interbody cage packing or post-filling. It is cleared by the FDA under a Traditional 510(k) pathway (K242797) as substantially equivalent to autograft, with no MRI safety restrictions specified. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What types of orthopedic procedures is the OsteoFlo HydroFiber specifically designed for, and how does its flowable nature benefit the surgeon during surgery?
The OsteoFlo HydroFiber is designed for spinal applications, particularly for filling bone voids such as interbody cage packing or post-filling scenarios. Its highly flowable, moldable composition allows it to conform to irregular bone defects, ensuring better structural integration. This property also helps resist migration under irrigation, which is critical during procedures where fluid pressure could displace less adaptable materials.
Is the OsteoFlo HydroFiber reusable, or is it intended for single-use only? How does this affect its clinical use and storage requirements?
The OsteoFlo HydroFiber is explicitly supplied as a single-use, sterile product, meaning it must not be reused after one surgical procedure. This design ensures patient safety by preventing cross-contamination and maintains sterility, which is critical for orthopedic applications. Clinicians must adhere to sterile medical device protocols for storage and handling to preserve its integrity until use.
What storage conditions should be followed for the OsteoFlo HydroFiber to maintain its sterility and performance?
Since the OsteoFlo HydroFiber is a sterile, single-use device, it must be stored in accordance with standard sterile medical device protocols. This includes keeping it in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and physical damage. Always follow the manufacturer’s instructions provided with the product to ensure sterility and performance are preserved until use.
How does the OsteoFlo HydroFiber differ from traditional bone graft materials in terms of handling and clinical application?
Unlike traditional bone graft materials (such as autograft or allograft), the OsteoFlo HydroFiber is a synthetic, fiber-based material that is designed to be highly flowable and moldable. This allows surgeons to easily pack it into bone voids, conform to complex spinal geometries, and resist displacement under irrigation—qualities that can simplify procedures like interbody fusions. Its synthetic composition also eliminates donor-site morbidity and variability issues associated with autograft.
What regulatory pathway was used for FDA clearance of the OsteoFlo HydroFiber, and what does this mean for clinicians considering its use?
The OsteoFlo HydroFiber was cleared by the FDA under a Traditional 510(k) pathway (K242797), with a decision code of SESE (Substantially Equivalent) to autograft. This means the FDA determined it has the same intended purpose and technological characteristics as a predicate device (autograft) while meeting safety and effectiveness requirements. Clinicians can rely on this clearance as evidence of its regulatory review, though they should always refer to the device’s labeling for specific surgical indications and usage instructions.
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: OsteoFlo® HydroFiber™ - surgentec.com, PDF OsteoFlo HydroFiber Brochure 1-14-25, SurGenTec, OsteoFlo HydroFiber (K243949) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242797 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgentec, Llc
Sources (1)
- FDA 510(k) K242797 24 fields · synced Sep 19, 2026