OsteoStrux Putty
OsteoStrux® Putty, 2.5cc - A resorbable bone void filler made from a bovine collagen matrix that has tricalcium phosphate (TCP) granules dispersed throughout.
2manufacturers in China registered for this device type
4catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this code
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 | Isotis Orthobiologics, Inc, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K062353 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 56070150 | 15cc | In distribution |
| 56070025 | 2.5cc | In distribution |
| 56070100 | 10cc | In distribution |
| 56070050 | 5cc | 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 |
|---|---|
| K070751 | 2007-10-15 |
| K052098 | 2005-09-07 |
| K050690 | 2005-07-07 |
| K040419 | 2005-03-25 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2011-10-11 | Class II | Employee error | The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term “bone marrow aspirate”. The term is incorrectly tran | 42 units | 2013-02-14 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-07 | Not classified | Error in labeling | Integra OS Osteoconductive Putty is labeled with incorrect storage conditions. | 45 units | 2013-05-21 |
| Integra Lifesciences Corporation | 510(k) number | 2009-01-16 | Not classified | Pending | Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained. | 88 units | 2009-06-25 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-07-02 | Class II | Process control | Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7 | 98 |
| 2024-11-27 | Class II | Under Investigation by firm | Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. | 145 |
| 2024-11-27 | Class II | Labeling Change Control | Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. | 22 |
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.