Cerasorb® Ortho Foam
Cerasorb Ortho Foam is a porous bone void filler made from beta-tricalcium phosphate and porcine collagen. It fills surgically created or traumatic gaps in the extremities or pelvis that do…
Cerasorb Ortho Foam is a porous bone void filler made from beta-tricalcium phosphate and porcine collagen. It fills surgically created or traumatic gaps in the extremities or pelvis that do not determine the bone’s structural stability.
The composite contains Type I and Type III collagen with interconnected ceramic pores. It provides a scaffold for bone growth and gradually resorbs during healing.
Listed Item
Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
Foam Forms
Flexible foam strips and mouldable foam versions are available in different dimensions. The material does not provide structural strength to the surgical site. Devices are supplied gamma sterilized for single use, with the selected foam form and size matched to the defect.
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 | 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) | K160566 |
| Record published | 2017-10-24 |
| Record revised | 2018-07-06 (version 3) |
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 number | Size | Status |
|---|---|---|
| 25x50x4 mm | In distribution | |
| 25x50x4 mm | In distribution | |
| 25x100x4 mm | In distribution | |
| 25x25x2 mm | In distribution | |
| 65x65x6 mm | In distribution | |
| 25x100x4 mm | In distribution | |
| 25x12x4 mm | In distribution |
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 |
|---|---|
| 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.