OsteoFlo HydroFiber – 6cc Labeled
OsteoFlo HydroFiber is a resorbable bone void filler for gaps in the pelvis, posterolateral spine or intervertebral disc space that are not essential to the bone’s structural stability. It…
OsteoFlo HydroFiber is a resorbable bone void filler for gaps in the pelvis, posterolateral spine or intervertebral disc space that are not essential to the bone’s structural stability. It can fill surgically created or traumatic defects, either alone or with autograft as a graft extender.
The material contains calcium phosphate and bioglass in a synthetic polymer binder. As the binder resorbs, it exposes particles that provide a scaffold for new bone formation. The filler is gradually resorbed and replaced by host bone during healing.
Preparation and Use
The single-use filler is supplied sterile and dry and requires mixing with an aqueous solution before gentle packing into the defect. In interbody fusion procedures, it must accompany 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-06 | 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.