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Osteo-P Bone Graft Substitute

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170165

by Molecular Matrix

Identifiers

510(k) Number
K170165 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)

Osteo-P Bone Graft Substitute is a non-mineralized, synthetic bone void filler consisting of a hyper-crosslinked carbohydrate polymer. It is highly porous, biocompatible, biodegradable, and osteoconductive. The device is intended for filling bone defects created surgically or as a result of traumatic injury.

Osteo-P Bone Graft Substitute is supplied as a sterile device and is for single use. It is MRI safe and available in various sizes. The device received FDA 510(k) clearance with the K number K170165 in 2017.

Frequently asked questions

What is Osteo-P Bone Graft Substitute used for?

Osteo-P is a non-mineralized, synthetic bone void filler designed to fill bone defects created surgically or as a result of traumatic injury. It is highly porous, biocompatible, biodegradable, and osteoconductive to support bone regeneration.

How is Osteo-P Bone Graft Substitute supplied and can it be reused?

Osteo-P is supplied as a sterile device and is intended for single use only. It is MRI safe and available in various sizes to accommodate different clinical needs. Reuse is not recommended as it may compromise sterility and performance.

What regulatory clearance has Osteo-P Bone Graft Substitute received?

Osteo-P Bone Graft Substitute received FDA 510(k) clearance with the K number K170165 in 2017. The clearance was determined through the traditional pathway with a decision code of SESE, indicating substantial equivalence to predicate devices.

How should Osteo-P Bone Graft Substitute be stored?

The device should be stored according to the manufacturer's instructions to maintain its integrity. While specific storage conditions are not detailed in the provided information, it is typically recommended to store sterile medical devices in a cool, dry place away from direct sunlight and extreme temperatures.

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: Osteo-P® BGS - Molecular Matrix, Molecular Matrix, Osteopoietic Systems Osteo-P Bone Graft Substitute (BGS)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Molecular Matrix
FDA Applicant
Molecular Matrix, Inc.

Sources (1)

  • FDA 510(k) K170165 24 fields · synced Sep 25, 2026