ThriveSynth™ Collagen Foam Putty

ThriveSynth™ Collagen Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules.…

Registry build 21.09.26

ThriveSynth™ Collagen Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite – 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. ThriveSynth™ Collagen Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.

2manufacturers in China registered for this device type
4catalogue numbers in this listing
14510(k) clearances naming this product code
1recall

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1).

Chinese manufacturers registered for FDA product code MQV
Manufacturer City Province Registered as Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Allgens Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 1

Record

Regulatory record for ThriveSynth™ Collagen Foam Putty
Listed by Berkeley Advanced Biomaterials, United States
FDA product code MQV
Device type Filler, Bone Void, Calcium Compound
Device class Class 2
Regulation 21 CFR 888.3045
Establishment Manufacturer
510(k) K092046
Record published 2026-05-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for ThriveSynth™ Collagen Foam Putty
Catalogue number Size Status
TSCFP-10 In distribution
TSCFP-02 In distribution
TSCFP-01 In distribution
TSCFP-05 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Synthacer medArtis Medizinprodukte und Forschung Aktiengesellschaft 360
Syntricer medArtis Medizinprodukte und Forschung Aktiengesellschaft 357
Biosorb S.B.M 65
MagnetOs Kuros Biosciences B.V 61
BioSet® Rti Surgical, Inc. 47
Bicera® Resorbable Bone Substitute Wiltrom Corporation Limited 41
GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) Medtronic Sofamor Danek, Inc. 40
Bicera® Resorbable Bone Substitute Wiltrom Co., Ltd. (Chutung) 39
ChronOS Synthes Gmbh 39
Synthacer/Syntricer medArtis Medizinprodukte und Forschung Aktiengesellschaft 36
Inion BioRestore™ Inion OY 35
Resorba Synthetic Bone Biomatlante 35

Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K170917 2017-10-30
K113791 2012-03-15
K091912 2010-06-23
K092046 2010-03-24
K053213 2006-07-06
K051914 2005-11-03
K051695 2005-07-19
K050666 2005-04-11
K042636 2004-12-14
K041889 2004-08-19
K040405 2004-03-05
K030266 2003-02-20
K023703 2003-01-30
K022622 2003-01-09

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2025-09-02 Class II Process control Due to incorrect product label (Incorrect product name identified on outer packaging). 62 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer