Device
ThriveSynth™ Calcium Putty is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, ThriveSynth™ Calcium Putty resorbs and is later replaced by natu...
Manufacturer
BERKELEY ADVANCED BIOMATERIALS, LLC
BERKELEY ADVANCED BIOMATERIALS, LLC
Model: TSCP-10
Catalog: TSCP-10
DI: 00816125026807
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™ Calcium Putty is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, ThriveSynth™ Calcium Putty resorbs and is later replaced by natural bone. ThriveSynth™ Calcium Putty 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™ Calcium Putty is an osteoconductive putty that is 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
919d9262-52f4-430a-8d7d-755bc6f3e5c0
Distribution Status:
In Commercial Distribution
DUNS Number:
081067703
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
00816125026807
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:
K022622
Supplement Number:
000