Device
ThriveSynth™ Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
Manufacturer
BERKELEY ADVANCED BIOMATERIALS, LLC
BERKELEY ADVANCED BIOMATERIALS, LLC
Model: TSPCK-10
Catalog: TSPCK-10
DI: 00816125026838
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™ Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1bcc08c9-b999-4851-9866-f448092f6e86
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:
00816125026838
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45105
Name: Orthopaedic cement spacer mould
Definition:
A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.
FDA Product Codes
MQV
Filler, Bone Void, Calcium Compound
Premarket Submissions
Submission Number:
K022622
Supplement Number:
000