BonVie+

Basic Information

• Brand Name: BonVie+
• Primary DI: 00199284455788
• Version / Model: EPBV-10ML
• Catalog Number: EPBV-10ML
• Company Name: ELUTE , INC.
• Labeler DUNS: 968551015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-13
• Public Version: 1
• Public Version Date: 2025-08-21
• Public Version Status: New
• Public Device Record Key: e6741d7d-8d0d-4f4f-baae-1bfc9960f154

Device Description

BonVie+ is a sterile, single-use, osteoconductive bone void filler intended to fill bony voids or gaps in the extremities and pelvis. It is supplied as a kit that includes a calcium salt and polymer powder, a mixing solution, and a silicone mat with cavities to form granules of various sizes. As the device resorbs, new bone gradually grows into the space previously occupied by the implant and replaces it during the healing process.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	888.3045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17751	Bone matrix implant, synthetic, non-antimicrobial	A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00199284455788	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250346	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter