OsteoFlo HydroFiber – 12cc Labeled
OsteoFlo HydroFiber is a resorbable filler for bone voids in the pelvis, posterolateral spine, or intervertebral disc space that do not determine structural stability. It may be used alone…
OsteoFlo HydroFiber is a resorbable filler for bone voids in the pelvis, posterolateral spine, or intervertebral disc space that do not determine structural stability. It may be used alone or with the patient’s own bone as a graft extender.
The material combines calcium phosphate and bioglass in a synthetic polymer binder. Supplied dry, it is mixed with an aqueous preparation before use and gently packed into the defect. It provides a scaffold as it is absorbed and replaced by host bone.
Preparation and Fusion Use
The product is supplied sterile for single use. Preparation may use saline or bone marrow aspirate. In intervertebral fusion procedures, it must be used with a fusion device cleared for use with a bone void filler.
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) | K242797 |
| Record published | 2026-03-09 |
| 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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HF-OSF-12 | 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.