OptiFuse BA Moldable Matrix 7888-1250

GUDID 00816125023905

OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips, and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 45S5 granules and hydroxyapatite-tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient’s new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00816125023905
• NIH Device Record Key: caf52dfe-a20b-4d78-a2b8-6a4ff97d07b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiFuse BA Moldable Matrix
• Version Model Number: 7888-1250
• Catalog Number: 7888-1250
• Company DUNS: 081067703
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816125023905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170917

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-24
• Device Publish Date: 2022-11-16

On-Brand Devices [OptiFuse BA Moldable Matrix]

• 00816125023905: OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized
• 00816125023899: OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized
• 00816125023882: OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized
• 00816125023875: OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized