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BioSphere Putty; BioSphere MIS Putty

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241167

by Synergy Biomedical

Identifiers

510(k) Number
K241167 FDA 510(k)
FDA Product Code
MQV FDA 510(k)
Models / Variants
BioSphere Putty FDA 510(k)
BioSphere MIS Putty 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)

BioSphere Putty and BioSphere MIS Putty are bioactive bone graft materials designed for orthopedic applications. They incorporate spherical bioactive glass particles within a resorbable phospholipid carrier, delivering a high bioactive glass content for enhanced bone regeneration and healing. The formulation supports osteoconductive and osteoinductive properties, making them suitable for filling defects and promoting bone integration in surgical procedures.

These products are supplied as sterile, single-use materials, intended for use in orthopedic surgeries, including minimally invasive techniques for the MIS variant. The BioSphere MIS Putty is engineered to be delivered via a cannula for precise application. Both variants comply with FDA 510(k) clearance under the product code MQV, ensuring regulatory adherence for orthopedic bone graft applications. Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What types of orthopedic procedures can BioSphere Putty and BioSphere MIS Putty be used for, and how do they differ in application?

BioSphere Putty and BioSphere MIS Putty are designed for orthopedic surgeries requiring bone regeneration, such as filling defects or promoting bone integration. The key difference lies in their application: BioSphere Putty is a general-purpose bioactive bone graft material for standard surgical use, while BioSphere MIS Putty is specifically engineered for minimally invasive procedures. The MIS variant is delivered via a cannula, allowing for precise, controlled placement in smaller or more confined surgical sites.

Are BioSphere Putty and BioSphere MIS Putty single-use or reusable, and how should they be stored to maintain sterility?

Both BioSphere Putty and BioSphere MIS Putty are sterile, single-use materials, meaning each package is intended for one surgical procedure only. To preserve sterility, they should be stored in their original packaging according to standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates and ensure the seal remains intact before use.

What makes the bioactive glass content in these products important for bone healing, and how does it differ from traditional bone grafts?

The bioactive glass particles in BioSphere Putty and BioSphere MIS Putty are formulated to deliver a high bioactive glass content, which supports both osteoconductive (providing a scaffold for new bone growth) and osteoinductive (stimulating stem cells to form new bone) properties. Unlike traditional bone grafts, which may rely solely on structural support or donor tissue, these products actively promote bone regeneration through their chemical interaction with the body, accelerating healing and integration at the defect site.

How do I confirm the regulatory compliance of BioSphere Putty and BioSphere MIS Putty before purchasing or using them?

Both products are FDA 510(k)-cleared under the product code MQV for orthopedic bone graft applications, with a decision date of December 20, 2024. The clearance was granted through the Orthopedic (OR) Advisory Committee under a traditional review process, confirming they meet U.S. regulatory standards for safety and effectiveness. Always verify the K-number (K241167) and check the manufacturer’s documentation for the latest compliance updates before use.

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: BioSphere Putty - Synergy Biomedical, BioSphere® MIS - Synergy Biomedical, BioSphere Putty Bioactive Bone Graft - medical-xprt.com, Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTY

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Synergy Biomedical

Sources (1)

  • FDA 510(k) K241167 24 fields · synced Sep 19, 2026