Futura™ CGT
Classic Flexible Great TOE Implant
4manufacturers in China registered for this device type
5catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | KWH |
| Device type | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3720 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2023-05-01 (version 4) |
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 |
| Distribution end date | 2023-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CGT-20 | Size 20 | Withdrawn |
| CGT-40 | Size 40 | Withdrawn |
| CGT-60 | Size 60 | Withdrawn |
| CGT-50 | Size 50 | Withdrawn |
| CGT-30 | Size 30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Profix | Smith & Nephew, Inc. | 138 |
| Sgarlato Silastic | Fusion Orthopedics, LLC | 51 |
| Swanson | Wright Medical Technology, Inc. | 29 |
| Integra® | Ascension Orthopedics, Inc. | 16 |
| Silicone Toe System | Smith & Nephew, Inc. | 13 |
| RTS | IN2BONES USA, LLC | 10 |
| Ascent Knee System | Biomet Orthopedics | 10 |
| Silktoe Spacer | BRM Extremities SRL | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 7 |
| OsteoMed | Osteomed | 6 |
| Futura™ FDI | Tornier Inc. | 6 |
| Orthoflex | Wright Medical Technology, Inc. | 4 |
Showing 12 of 14. All products under Prosthesis, Toe, Constrained, Polymer
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-04-06 | Not classified | Labeling mix-ups | Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great T | 77 | 2011-12-17 |
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.