Device
ThriveSynth™ HA/TCP Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. ThriveSynth™ HA/TCP Granules is safe and has excellen...
Manufacturer
BERKELEY ADVANCED BIOMATERIALS, LLC
BERKELEY ADVANCED BIOMATERIALS, LLC
Model: TSHG-30G
Catalog: TSHG-30G
DI: 00816125026760
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™ HA/TCP Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. ThriveSynth™ HA/TCP Granules is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. ThriveSynth™ HA/TCP Granules is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
ThriveSynth™ HA/TCP Granules is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The ThriveSynth™ HA/TCP Granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. ThriveSynth™ HA/TCP Granules is biocompatible and resorbs in the body as bone ingrowth occurs.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
deb6319a-9aff-4980-9d4c-dccfa1242f54
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:
00816125026760
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:
K023703
Supplement Number:
000