Who else makes this device?

Name: TriForm Moldable Foam
Brand: TriForm Moldable Foam

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

TriForm Moldable Foam

Device Name: TriForm Indication for Use: TriForm™ is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or…

Registry build 21.09.26

Device Name: TriForm Indication for Use: TriForm™ is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine TriForm™ is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.

2manufacturers in China registered for this device type

2catalogue numbers in this listing

6510(k) clearances naming this product code

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 TriForm Moldable Foam
Listed by	Curasan AG, Germany
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Specification developer, Manufacturer
510(k)	K181721
Record published	2026-06-25

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

Catalogue Numbers

Catalogue numbers for TriForm Moldable Foam
Catalogue number	Size	Status
25x100x4 mm		In distribution
25x50x4 mm		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
K181721	2018-09-17
K160566	2016-12-02
K100841	2010-08-19
K040216	2004-03-26
K031651	2003-08-13
K014156	2002-03-18

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.