Agilon Strip
Agilon Strip is a flexible, resorbable bone graft substitute made from osteoSPAN granules held by Type I collagen fibers. The strip can be shaped and contained within skeletal defects. The…
Agilon Strip is a flexible, resorbable bone graft substitute made from osteoSPAN granules held by Type I collagen fibers. The strip can be shaped and contained within skeletal defects.
The 1 to 2 mm granules are porous calcium carbonate with a thin calcium-phosphate layer throughout their interconnected pores. The material provides an osteoconductive scaffold that is replaced by bone as healing progresses.
Anatomical Use
It fills voids or gaps in the extremities, pelvis or posterolateral spine that are not intrinsic to structural stability. It may be used alone in the extremities or pelvis but must be mixed with autograft in the posterolateral spine.
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 | Biogennix, LLC, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K193487 |
| Record published | 2025-01-10 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010L-AGS | In distribution | |
| 015-AGS | In distribution | |
| 007-AGS | In distribution | |
| 005-AGS | 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 |
|---|---|
| K240621 | 2024-04-30 |
| K193487 | 2020-03-30 |
| K193168 | 2020-02-13 |
| K190371 | 2019-08-09 |
| K142828 | 2015-01-15 |
| K132377 | 2014-05-20 |
| K093342 | 2010-07-29 |
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.