ThriveSynth™ Bioactive Glass Foam Putty

ThriveSynth™ Bioactive Glass Foam Putty is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive…

Registry build 21.09.26

ThriveSynth™ Bioactive Glass Foam Putty 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.

2manufacturers in China registered for this device type
3catalogue 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™ Bioactive Glass 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) K170917
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™ Bioactive Glass Foam Putty
Catalogue number Size Status
TSBGP-01 In distribution
TSBGP-10 In distribution
TSBGP-05 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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BioSet® Rti Surgical, Inc. 47
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ChronOS Synthes Gmbh 39
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Inion BioRestore™ Inion OY 35
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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 Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of ThriveSynth™ Bioactive Glass Foam Putty
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Berkeley Advanced Biomaterials 510(k) number 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