TalarLift STS
TalarLift STS is a threaded subtalar implant for treatment of the hyperpronated foot and stabilization of the subtalar joint. It is positioned between the posterior and middle facets. The…
TalarLift STS is a threaded subtalar implant for treatment of the hyperpronated foot and stabilization of the subtalar joint. It is positioned between the posterior and middle facets. The system includes cylindrical, conical and anatomic implant configurations, with instruments to assist placement.
The implant is made from titanium alloy. Its shape is intended to block posterior and inferior displacement of the talus while permitting normal subtalar motion and limiting excessive pronation. The cylindrical component belongs to this subtalar stabilization range.
Listed Item
Cylindrical ST Implant 10mm (Sterile)
Intended Foot Conditions
Indications include hypermobile pes valgus, posterior tibial tendon dysfunction, severe pronation, subtalar instability and hypermobile flexible congenital flatfoot. These conditions may result from disease, injury or other trauma. The implant is an arthroereisis device intended to limit excessive joint motion.
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K170624 |
| Record published | 2019-04-29 |
| Record revised | 2024-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TN-TL-1012 | In distribution | |
| CD-TL-2020 | In distribution | |
| TL-CY-0007 | In distribution | |
| TL-CN-0007-S | In distribution | |
| TL-AT-0008 | In distribution | |
| TL-CY-0008 | In distribution | |
| TL-CN-0009-S | In distribution | |
| TL-CN-0009 | In distribution | |
| TL-CY-0007 | In distribution | |
| TN-TL-2010 | In distribution | |
| TN-TL-2009 | In distribution | |
| TL-CY-0009 | In distribution | |
| TL-CY-0010-S | In distribution | |
| TL-CN-0011 | In distribution | |
| TL-CY-0011 | In distribution | |
| TN-TL-1007 | In distribution | |
| TL-AT-0011 | In distribution | |
| TN-TL-3010 | In distribution | |
| TL-AT-0009-S | In distribution | |
| TL-CY-0012-S | In distribution | |
| TL-CY-0011 | In distribution | |
| TL-CY-0010 | In distribution | |
| TN-TL-4000 | In distribution | |
| TL-CN-0010 | In distribution | |
| TL-CY-0008 | In distribution | |
| TL-AT-0012 | In distribution | |
| TL-CY-0012 | In distribution | |
| TN-TL-2012 | In distribution | |
| TL-CN-0007 | In distribution | |
| TN-TL-3007 | In distribution | |
| TL-CN-0008-S | In distribution | |
| TN-TL-3008 | In distribution | |
| TL-CY-0010 | In distribution | |
| TN-TL-3009 | In distribution | |
| TL-AT-0007 | In distribution | |
| TL-CY-0011-S | In distribution | |
| TN-TL-1008 | In distribution | |
| TN-TL-3011 | In distribution | |
| TL-CY-0009-S | In distribution | |
| TN-TL-2007 | In distribution | |
| TL-AT-0007-S | In distribution | |
| TL-CN-0012-S | In distribution | |
| CD-TL-5050 | In distribution | |
| TN-TL-1011 | In distribution | |
| TN-TL-1009 | In distribution | |
| TL-CY-0007-S | In distribution | |
| TL-AT-0012-S | In distribution | |
| TL-CN-0007 | In distribution | |
| TL-CN-0010-S | In distribution | |
| TN-TL-6060 | In distribution | |
| TL-CY-0009 | In distribution | |
| TL-CN-0008 | In distribution | |
| TL-AT-0009 | In distribution | |
| CD-TL-5010 | In distribution | |
| TN-TL-1010 | In distribution | |
| TL-AT-0008-S | In distribution | |
| TL-CN-0012 | In distribution | |
| TN-TL-2008 | In distribution | |
| TL-CN-0011 | In distribution | |
| TL-CN-0010 | In distribution | |
| TN-TL-3012 | In distribution | |
| TL-AT-0010-S | In distribution | |
| TL-CY-0008-S | In distribution | |
| TL-CN-0009 | In distribution | |
| TL-AT-0011-S | In distribution | |
| TL-CN-0011-S | In distribution | |
| TL-CN-0008 | In distribution | |
| TL-AT-0010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210159 | 2021-07-23 |
| K182342 | 2019-05-21 |
| K182684 | 2018-11-23 |
| K170624 | 2017-08-11 |
| K170038 | 2017-08-07 |
| K161449 | 2016-10-11 |
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.