Stimulan® Kit
Stimulan Kit is a calcium-sulfate bone void filler supplied as powder and mixing solution. Mixing forms a paste that can be injected, placed manually or applied to a mould to make pellets.…
Stimulan Kit is a calcium-sulfate bone void filler supplied as powder and mixing solution. Mixing forms a paste that can be injected, placed manually or applied to a mould to make pellets. The material resorbs and is replaced by bone during healing.
It is intended for skeletal voids or gaps that are not intrinsic to bone stability, including extremities, pelvis and posterolateral spine. Defects may result from surgery, trauma, cysts, tumors or osteomyelitis. Use at an infected site is included in the described indication.
Listed Item
STIMULAN® Kit – provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 → 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
Filler Role
The material is gently packed into the defect as a graft substitute rather than used as a load-bearing structural implant. The kit and Rapid Cure forms share the described calcium-sulfate material and void-filling role. The supplied mould is used to shape pellets when that application form is selected.
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| 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
| 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 | 2020-01-07 |
| Record revised | 2020-11-02 (version 4) |
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 |
| Distribution end date | 2020-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600-010 | 10cc | In distribution |
| 600-005 | 5cc | In distribution |
| 600-005 | 5cc | Withdrawn |
| 600-010 | 10cc | Withdrawn |
Same 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
| 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.
| 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.