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OSferion

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080065

by Olympus Terumo Biomaterials Corporation

Identifiers

510(k) Number
K080065 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)

OSferion is a bone graft substitute classified as a bone graft, synthetic under the FDA’s product code MQV. It is designed to provide structural support and promote bone regeneration in orthopedic applications, particularly for spinal and orthopedic surgeries requiring bone void filling or augmentation.

The device is supplied as a sterile, single-use synthetic bone graft substitute and is intended for use in surgical settings. It is regulated under FDA 510(k) clearance (K080065) with a Traditional review pathway, classified under the Orthopedic Advisory Committee. Storage and handling instructions are not specified in the provided data, but compliance with sterile surgical protocols is implied for clinical use.

Frequently asked questions

What types of surgeries is OSferion primarily intended for, and how does it function in those procedures?

OSferion is designed for spinal and orthopedic surgeries where bone void filling or augmentation is required. It acts as a synthetic bone graft substitute to provide structural support and promote bone regeneration, helping to fill gaps or reinforce areas where natural bone may be insufficient or damaged.

Is OSferion reusable, or is it meant for single-use only? How does this affect its clinical use?

OSferion is explicitly supplied as a sterile, single-use device. This ensures clinical safety and consistency, as reuse could compromise sterility and integrity, potentially leading to infection or performance issues. Each package is intended for one surgical procedure only.

What regulatory pathway was followed for OSferion’s FDA clearance, and which advisory committee was involved?

OSferion received FDA clearance through the 510(k) Traditional review pathway, classified under the Orthopedic Advisory Committee (OR). The device was determined to be substantially equivalent to a predicate, as indicated by the decision code *SESE* (Substantially Equivalent, Same Technology).

How should OSferion be stored, and what precautions should be taken before use?

While specific storage instructions aren’t detailed in the provided data, OSferion is a sterile device intended for surgical use. Clinicians should follow standard sterile surgical protocols, including proper handling, sealing, and expiration checks to maintain integrity before use.

What are the key differences between OSferion and traditional bone grafts, and why might a surgeon choose it?

OSferion is a synthetic bone graft substitute, unlike autologous or allograft bone grafts, which rely on patient-derived or donor tissue. It provides a consistent, off-the-shelf option for structural support and bone regeneration without donor-site morbidity or variability. Surgeons may prefer it for its predictable performance, ease of use, and avoidance of potential complications tied to biological grafts.

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: OSferionBiomaterials Corp., Corporate Profile & Company Profile | Company - Biomaterial, Notice of Stock Change of Olympus Terumo Biomaterials

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Terumo Biomaterials Corporation

Sources (1)

  • FDA 510(k) K080065 24 fields · synced Sep 19, 2026