Adaptos®Fuse
AdaptosFuse is a bioactive bone void filler supplied as granules in open-bore syringes. It fills skeletal gaps that do not themselves determine the structural stability of the bone. The…
AdaptosFuse is a bioactive bone void filler supplied as granules in open-bore syringes. It fills skeletal gaps that do not themselves determine the structural stability of the bone.
The granules combine PLCL polymer, tricalcium phosphate and bioactive glass. They are mixed with the patient’s own bone graft before placement and gradually resorb as bone replaces the graft material during healing.
Listed Item
Adaptos®Fuse Bone Graft 1.0-2.0 mm granules 10 cc
Graft Applications
Applications include specified defects in the pelvis, posterolateral spine and interbody fusion procedures. Interbody use requires a compatible fusion device intended for bone void filler. The listed presentation contains 1.0 to 2.0 mm granules in a 10 cc volume, with other package sizes available within the family.
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 | Biomendex OY, Finland |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer |
| 510(k) | K253524 |
| Record published | 2026-06-24 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H212006 | In distribution | |
| H212004 | In distribution | |
| H212003 | In distribution | |
| H212005 | 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 |
|---|---|
| K253524 | 2026-02-17 |
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.