Stimulan® Rapid Cure
STIMULAN Rapid Cure fills bone voids or gaps that do not determine the structural stability of the bone. It is used for defects created by surgery or injury in areas such as the…
STIMULAN Rapid Cure fills bone voids or gaps that do not determine the structural stability of the bone. It is used for defects created by surgery or injury in areas such as the extremities, pelvis and posterolateral spine. It provides a calcium sulfate bone graft substitute.
Powder and mixing solution are combined to form a paste. The paste can be placed into a bone defect or formed into pellets using a mould. The material is absorbed over time as bone replaces it during healing.
Listed Item
STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure 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 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® Rapid Cure 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.
Placement Limits
The filler is intended for defects that do not require it to supply structural stability. Its biodegradable, biocompatible material may be used at an infected site. It does not serve as load bearing fixation hardware.
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 | 2015-04-01 |
| 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 |
|---|---|---|
| 620-020 | 20CC | In distribution |
| 620-005 | 5cc | In distribution |
| 620-003 | 3cc | In distribution |
| 620-010 | 10cc | In distribution |
| 620-010 | 10cc | Withdrawn |
| 620-020 | 20CC | Withdrawn |
| 620-005 | 5cc | 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.