OsteoFlo Synthetic NanoPutty Syringe- 5cc
OsteoFlo NanoPutty is a synthetic bone void filler for gaps in the extremities or pelvis that do not provide essential structural stability. It is placed into defects created by surgery or…
OsteoFlo NanoPutty is a synthetic bone void filler for gaps in the extremities or pelvis that do not provide essential structural stability. It is placed into defects created by surgery or traumatic injury. The material gradually resorbs and is replaced by bone during healing.
The nonhardening putty contains porous calcium phosphate particles in a resorbable polymer binder. The particles combine hydroxyapatite, alpha and beta tricalcium phosphate and bioactive glass, with additional microsized hydroxyapatite. As the binder and particles resorb, the porous particles provide a scaffold on and between which new bone can form.
Preparation and Supply
The putty is supplied sterile for one use and is ready for placement without mixing. It can be packed into the defect and adheres to bone surfaces. The listed syringe contains 5 cc within the supported 1 to 10 mL product range.
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 | Surgentec 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) | K200064 |
| Record published | 2020-11-19 |
| Record revised | 2026-05-05 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONP-S-05 | 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 |
|---|---|
| K251720 | 2025-07-02 |
| K243949 | 2025-05-28 |
| K242797 | 2024-12-23 |
| K231716 | 2023-10-02 |
| K200064 | 2020-08-14 |
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.