OsteoFlo Synthetic NanoPutty Syringe- 510cc
OsteoFlo NanoPutty is a synthetic bone void filler for gaps or defects in the extremities and pelvis that do not provide essential structural stability. It is intended for defects created…
OsteoFlo NanoPutty is a synthetic bone void filler for gaps or defects in the extremities and pelvis that do not provide essential structural stability. It is intended for defects created surgically or by traumatic injury and is gradually resorbed and replaced by bone during healing.
The non-hardening putty contains porous calcium phosphate particles and bioactive glass in a resorbable polymer binder, together with smaller hydroxyapatite particles. As the binder resorbs, the porous particles provide surfaces on and between which bone can form.
Preparation and Supply
The putty is supplied ready to use without mixing and can be packed into the defect. It is a sterile, single-use material supplied in several package formats.
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-10 | 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.