Sole Medial Column Fusion Plate
The SOLE Medial Column Fusion Plate fixes bones in the foot and ankle during fusion, fracture repair and reconstructive procedures. The plate is secured with locking or nonlocking bone…
The SOLE Medial Column Fusion Plate fixes bones in the foot and ankle during fusion, fracture repair and reconstructive procedures. The plate is secured with locking or nonlocking bone screws. Its medial column applications include the first metatarsal, medial cuneiform, navicular and talus.
Plates are available in different shapes and sizes, with screw diameters and lengths selected for the fixation. The plate and screws are made from stainless steel. The system is intended for use in an operating theatre, with instruments supporting insertion and removal.
Listed Item
Sole MCF SS Plate Standard Extended Large Right Sterile
Use Scope
The implants are for single use. Listed procedures include arthrodesis, stabilization of joint depression, fracture or osteotomy fixation, reconstruction and revision, including procedures for Charcot neuroarthropathy. The screws are not intended for spinal use.
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 | Orthofix SRL, Italy |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K210157 |
| Record published | 2021-06-03 |
| Record revised | 2025-11-20 (version 6) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | In distribution |
| 1 | Height 2 mm | 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 |
|---|---|
| K210157 | 2021-04-20 |
| K200246 | 2020-05-22 |
| K190388 | 2019-06-07 |
| K102201 | 2010-12-15 |
| K101936 | 2010-10-20 |
| K051945 | 2005-09-06 |
| K042766 | 2004-11-16 |
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.