Footmotion Plating System
Footmotion is a system of plates and screws used to stabilize bones in the adult foot. It supports fixation during fracture treatment, osteotomy, joint fusion and revision surgery. The…
Footmotion is a system of plates and screws used to stabilize bones in the adult foot. It supports fixation during fracture treatment, osteotomy, joint fusion and revision surgery.
The implant materials include commercially pure titanium and Ti-6Al-4V ELI titanium alloy. The plates and screws form the implanted fixation construct; the accompanying instruments are used to place it during surgery.
Supply and Preparation
Implants are available either nonsterile for sterilization before use or sterile after gamma sterilization. The surgical instruments are supplied nonsterile and require sterilization by the healthcare facility.
22manufacturers in China registered for this device type
124catalogue numbers in this listing
25510(k) clearances naming this product code
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 | Newclip Technics SAS, France |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K221395 |
| Record published | 2024-11-14 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FSTDL1 | In distribution | |
| FVTSL8 | In distribution | |
| FBTDMV1 | In distribution | |
| FMTGDN2 | In distribution | |
| FRTDMV1-ST | In distribution | |
| FBTGMV1 | In distribution | |
| FCTSM6.5-ST | In distribution | |
| KIT-MD3G | In distribution | |
| FLTGMV2 | In distribution | |
| FCTSM0 | In distribution | |
| FLTDV0-ST | In distribution | |
| FLTDMV2-ST | In distribution | |
| FRTGMV2-ST | In distribution | |
| KIT-MD2D | In distribution | |
| KIT-LV1D-CQ4.0 | In distribution | |
| FLTDV2-ST | In distribution | |
| FSTGL4-ST | In distribution | |
| FATSL10-ST | In distribution | |
| FSTGL2-ST | In distribution | |
| KIT-MD1G | In distribution | |
| FVTSL0-ST | In distribution | |
| FMTGDN4-ST | In distribution | |
| FRTGMV2 | In distribution | |
| FKTDL3-ST | In distribution | |
| FRTDMV1 | In distribution | |
| FMTDDN4-ST | In distribution | |
| FATSL7.5 | In distribution | |
| FATSL5-ST | In distribution | |
| FLTDV1-ST | In distribution | |
| FLTDMV1-ST | In distribution | |
| FMTDDN2 | In distribution | |
| FLTDMV1 | In distribution | |
| FUTDD1-ST | In distribution | |
| FBTGMV1-ST | In distribution | |
| FBTGMV2 | In distribution | |
| FKTGL3 | In distribution | |
| FTTSM1-ST | In distribution | |
| KIT-MD3D | In distribution | |
| FCTSM0-ST | In distribution | |
| FKTGL1-ST | In distribution | |
| FFTDD1 | In distribution | |
| FATSL10 | In distribution | |
| FKTDL2-ST | In distribution | |
| FMTDDN4 | In distribution | |
| KIT-MDN1G | In distribution | |
| FLTGMV0-ST | In distribution | |
| FSTDL4-ST | In distribution | |
| FVTSL10 | In distribution | |
| FKTDL1-ST | In distribution | |
| FSTGL1-ST | In distribution | |
| FKTGL3-ST | In distribution | |
| FSTGL1 | In distribution | |
| FLTDV1 | In distribution | |
| FCTSM5.5-ST | In distribution | |
| FATSL7.5-ST | In distribution | |
| FSTDL1-ST | In distribution | |
| FSTGL3 | In distribution | |
| FKTDL1 | In distribution | |
| FLTSM1 | In distribution | |
| FMTGDN4 | In distribution | |
| FTTSM2 | In distribution | |
| FSTDL4 | In distribution | |
| FTTSM2-ST | In distribution | |
| FMTDDN2-ST | In distribution | |
| FSTGL4 | In distribution | |
| KIT-MD1D | In distribution | |
| FVTSL6-ST | In distribution | |
| KIT-LV2D-CQ4.0 | In distribution | |
| FLTGV1-ST | In distribution | |
| FUTSD1 | In distribution | |
| FVTSL0 | In distribution | |
| FFTGD1-ST | In distribution | |
| FLTGV2 | In distribution | |
| KIT-LV0D-CQ4.0 | In distribution | |
| FLTDMV2 | In distribution | |
| FSTDL2 | In distribution | |
| FCTSM5.5 | In distribution | |
| FMTDDN1-ST | In distribution | |
| FSTDL3 | In distribution | |
| FLTGMV1 | In distribution | |
| FRTGMV1-ST | In distribution | |
| FLTDMV0 | In distribution | |
| FLTGV0 | In distribution | |
| FBTGMV2-ST | In distribution | |
| FMTDD4 | In distribution | |
| FVTSL8-ST | In distribution | |
| FTTSM1 | In distribution | |
| FSTDL2-ST | In distribution | |
| FUTSD1-ST | In distribution | |
| FCTSM4.5-ST | In distribution | |
| FLTGV1 | In distribution | |
| FUTGD1-ST | In distribution | |
| FKTDL2 | In distribution | |
| FKTGL2 | In distribution | |
| FLTGV0-ST | In distribution | |
| FLTDV0 | In distribution | |
| FBTDMV2-ST | In distribution | |
| KIT-MDN1D | In distribution | |
| KIT-MD2G | In distribution | |
| FVTSL6 | In distribution | |
| FLTGMV1-ST | In distribution | |
| KIT-LV1G-CQ4.0 | In distribution | |
| FMTGDN1-ST | In distribution | |
| FRTDMV2 | In distribution | |
| FCTSM4.5 | In distribution | |
| FMTGD4 | In distribution | |
| FMTGD4-ST | In distribution | |
| FLTGMV0 | In distribution | |
| FSTDL3-ST | In distribution | |
| FVTSL10-ST | In distribution | |
| FBTDMV2 | In distribution | |
| FCTSM6.5 | In distribution | |
| FLTDMV0-ST | In distribution | |
| FUTGD1 | In distribution | |
| FATSL5 | In distribution | |
| FLTGMV2-ST | In distribution | |
| FKTGL1 | In distribution | |
| FFTGD1 | In distribution | |
| KIT-LV0G-CQ4.0 | In distribution | |
| KIT-LV2G-CQ4.0 | In distribution | |
| FLTDV2 | In distribution | |
| FRTGMV1 | In distribution | |
| FBTDMV1-ST | In distribution | |
| FRTDMV2-ST | 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 |
|---|---|
| K261511 | 2026-07-28 |
| K261191 | 2026-07-08 |
| K261038 | 2026-05-29 |
| K253906 | 2026-03-11 |
| K250155 | 2025-04-23 |
| K241539 | 2024-07-30 |
| K221395 | 2022-07-01 |
| K202803 | 2021-12-16 |
| K213214 | 2021-11-24 |
| K202307 | 2020-11-17 |
| K173746 | 2018-02-27 |
| K173641 | 2018-01-16 |
| K171372 | 2018-01-04 |
| K171510 | 2017-09-08 |
| K170843 | 2017-06-16 |
| K170310 | 2017-03-30 |
| K161448 | 2016-10-31 |
| K152289 | 2016-08-17 |
| K141548 | 2015-01-30 |
| K143061 | 2015-01-26 |
| K142502 | 2014-12-23 |
| K130774 | 2013-06-19 |
| K100944 | 2010-10-22 |
| K063095 | 2006-12-22 |
| K061917 | 2006-08-28 |
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.