Tarsa Link Bunion
The Tarsa-Link C-Shaped Wedge is an implant for internal fixation during fractures, fusions or osteotomies of the foot and ankle. Its applications include opening-wedge correction of hallux…
The Tarsa-Link C-Shaped Wedge is an implant for internal fixation during fractures, fusions or osteotomies of the foot and ankle. Its applications include opening-wedge correction of hallux valgus, Evans lengthening osteotomies and metatarsal or cuneiform arthrodesis.
The wedge has two pockets through which titanium bone screws provide internal fixation. The listed midline configuration places these screw pockets along the implant’s midline. The C-shaped footprint is offered for procedures where bone graft is not required.
Listed Item
18mm x 9mm x 5mm, Tarsa-Link C-Shaped Wedge, Midline
Implant Use
The wedge is intended for a single use. Components are used within the Tarsa-Link Stand-Alone Wedge Fixation System and must not be mixed with components from another system or manufacturer.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| 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 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Life Spine, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K161037 |
| Record published | 2019-11-07 |
| Record revised | 2021-06-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-1411-705 | In distribution | |
| 114-220 | In distribution | |
| 154-156 | In distribution | |
| 154-153 | In distribution | |
| 154-001 | In distribution | |
| 154-5-010 | In distribution | |
| 154-5-018 | In distribution | |
| 154-152 | In distribution | |
| 114-221-2 | In distribution | |
| 30-1411-708 | In distribution | |
| 154-136 | In distribution | |
| 154-149 | In distribution | |
| 154-154 | In distribution | |
| 154-5-012 | In distribution | |
| 30-1411-707 | In distribution | |
| 154-6-010 | In distribution | |
| 154-5-016 | In distribution | |
| 154-6-016 | In distribution | |
| 154-207 | In distribution | |
| 114-221-3 | In distribution | |
| 114-221-1 | In distribution | |
| 154-151 | In distribution | |
| 154-6-020 | In distribution | |
| 154-6-018 | In distribution | |
| 154-5-014 | In distribution | |
| 154-144 | In distribution | |
| 154-205 | In distribution | |
| 154-6-014 | In distribution | |
| 154-135 | In distribution | |
| 30-1411-706 | In distribution | |
| 154-5-020 | In distribution | |
| 154-206 | In distribution | |
| 30-1411-704 | In distribution | |
| 154-6-012 | In distribution | |
| 154-6-008 | In distribution | |
| 154-5-008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172973 | 2017-12-21 |
| K161037 | 2016-08-15 |
| K150368 | 2015-03-24 |
| K141905 | 2014-09-26 |
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.