Putty MIS System 10.0cc
The NovaBone Putty MIS System delivers a premixed bone void filler through a long cartridge attached to a dispensing handle. It is used for nonstructural bone gaps in the extremities,…
The NovaBone Putty MIS System delivers a premixed bone void filler through a long cartridge attached to a dispensing handle. It is used for nonstructural bone gaps in the extremities, pelvis or posterolateral spine, including defects created by surgery or trauma.
The cohesive putty contains bioactive glass particles in a synthetic binder. After implantation, the binder resorbs to allow tissue infiltration between the particles. The remaining particles act as a scaffold for bone growth and are gradually replaced by bone.
Delivery and Stability
The sterile, prefilled polypropylene cartridge provides access to deeper defect sites. The filler is gently packed into the void, alone or with autogenous bone. It is not load-bearing, so appropriate internal or external stabilization is required.
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) | K112773 |
| Record published | 2016-03-07 |
| Record revised | 2020-06-19 (version 4) |
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 |
|---|---|---|
| NB6610 | 10.0cc | In distribution |
| NB6710 | 10.0cc | In distribution |
| NB6710TM | 10.0cc | 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.