Who else makes this device?

Name: Signafuse
Brand: Signafuse

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Signafuse

Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable…

Registry build 21.09.26

Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

2manufacturers in China registered for this device type

3catalogue numbers in this listing

3510(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 Signafuse
Listed by	Bioventus LLC, United States
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K132071
Record published	2019-02-22
Record revised	2020-07-29 (version 4)

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
Storage	Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Signafuse
Catalogue number	Size	Status
3.75g		In distribution
15g		In distribution
7.5g		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
K233490	2023-12-05
K193513	2020-06-18
K162860	2017-02-13

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 Signafuse
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Bioventus LLC	510(k) number	2019-02-13	Class II	Package design/selection	The firm became aware of the potential for the products’ sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.	10,793	2020-11-02

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.