MacroFORM Bioactive Packable Graft 5.0cc
MacroFORM Bioactive Packable Graft is a bone void filler for defects in the extremities and pelvis caused by surgery or traumatic injury. It is intended for gaps that do not determine the…
MacroFORM Bioactive Packable Graft is a bone void filler for defects in the extremities and pelvis caused by surgery or traumatic injury. It is intended for gaps that do not determine the stability of the surrounding bone structure.
The graft combines bioactive calcium phosphosilicate granules with a bovine collagen binder. When mixed with the patient’s own bone marrow, it forms a nonhardening material that can be gently packed into the defect.
Preparation and Function
Hydration with autogenous bone marrow is required before implantation. The graft provides an osteoconductive scaffold and is gradually absorbed and replaced by bone during healing. It is not a load-bearing substitute for structural bone.
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 | Novabone Products, LLC, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer |
| 510(k) | K140946 |
| Record published | 2016-03-09 |
| 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 |
| Storage | Storage environment temperature up to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NB0305 | 5.0cc | In distribution |
| NB0399 | 5.0cc | 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 |
|---|---|
| K242299 | 2024-09-25 |
| K240404 | 2024-03-05 |
| K163310 | 2017-01-18 |
| K152071 | 2015-08-26 |
| K141207 | 2014-10-31 |
| K140946 | 2014-08-22 |
| K112773 | 2011-10-14 |
| K110925 | 2011-07-05 |
| K110368 | 2011-04-14 |
| K101860 | 2010-09-01 |
| K090731 | 2009-04-15 |
| K082672 | 2008-12-09 |
| K080009 | 2008-05-06 |
| K060728 | 2006-05-01 |
| K060432 | 2006-04-04 |
| K051617 | 2006-03-06 |
| K052494 | 2005-11-03 |
| K041613 | 2004-08-25 |
| K021336 | 2002-07-25 |
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.