Who else makes this device?

Name: Stimulan Kit 5cc (China Only)
Brand: Stimulan Kit 5cc (China Only)

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Stimulan Kit 5cc (China Only)

(CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile…

Registry build 21.09.26

(CHINA ONLY) Stimulan® Calcium Sulphate Kit is provided sterile for single patient use. The Kit contains calcium sulphate powder. When the powder is mixed with sterile water in a sterile mixing bowl, the resultant paste is to be injected, digitally packed into open bone void/gap to cure in situ or placed into a mould, the mixture sets to form Stimulan® pellets. The biodegradable, radiopaque pellets are resorbed in approximately 30 – 60 days when used in accordance with the device labelling.

2manufacturers in China registered for this device type

1catalogue number

11510(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 Stimulan Kit 5cc (China Only)
Listed by	Biocomposites Ltd., United Kingdom
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)	K141830
Record published	2022-11-12

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 4 to 45 °C; Storage environment temperature 39 to 113 °F

Catalogue Numbers

Catalogue numbers for Stimulan Kit 5cc (China Only)
Catalogue number	Size	Status
600-005	5cc	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
K250521	2025-04-07
K212721	2022-02-04
K141830	2015-01-23
K082381	2008-11-14
K073341	2008-07-09
K061311	2006-09-22
K043514	2005-01-21
K040600	2004-05-07
K021551	2002-11-01
K003954	2001-07-12
K001724	2000-08-04

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 Stimulan Kit 5cc (China Only)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biocomposites Ltd.	510(k) number	2020-11-12	Class II	Labeling mix-ups	The product is mislabeled.	54 boxes	2021-04-27

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.