Ceracell Ortho Foam
Ceracell Ortho Foam fills bone voids or gaps in the posterolateral spine that do not provide intrinsic structural stability. These defects may arise surgically or from traumatic injury. The…
Ceracell Ortho Foam fills bone voids or gaps in the posterolateral spine that do not provide intrinsic structural stability. These defects may arise surgically or from traumatic injury. The material must be mixed with autograft in this spinal application.
The porous composite contains 85% resorbable beta-tricalcium phosphate ceramic granules and 15% porcine collagen scaffold by weight. The scaffold includes Type I and Type III collagen.
Listed Item
Device Name: CERACELL® Ortho Foam Indication for Use: CERACELL® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine CERACELL® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.
Forms and Healing
The material resorbs and is replaced by bone during healing. Flexible foam strips range from 2.5 to 25 cc, while moldable foam ranges from 1.2 to 25 cc, allowing selection for the shape and volume of 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) | K181721 |
| Record published | 2026-06-25 |
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 |
|---|---|---|
| 25x25x4 mm | In distribution | |
| 25x100x4 mm | In distribution | |
| 25x50x4 mm | In distribution | |
| 25x12x4 mm | In distribution | |
| 25x100x4 mm | In distribution | |
| 25x50x4 mm | In distribution | |
| 65x65x6 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.