Device
ThriveSynth™ Bioactive Glass Foam Strip is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 b...
Manufacturer
BERKELEY ADVANCED BIOMATERIALS, LLC
BERKELEY ADVANCED BIOMATERIALS, LLC
Model: TSBGS1-100X25-12
Catalog: TSBGS1-100X25-12
DI: 00816125026579
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
ThriveSynth™ Bioactive Glass Foam Strip 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.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c3f47a63-56fe-4e94-b312-ce860e1d4b96
Distribution Status:
In Commercial Distribution
DUNS Number:
081067703
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00816125026579
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17751
Name: Bone matrix implant, synthetic, non-antimicrobial
Definition:
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.
FDA Product Codes
MQV
Filler, Bone Void, Calcium Compound
Premarket Submissions
Submission Number:
K170917
Supplement Number:
000