Juniortho Plating System
JuniOrtho Plating System is a family of plates and bone screws for internal fixation of the femur and tibia. Plate shapes and sizes are matched to these anatomical regions, with locking and…
JuniOrtho Plating System is a family of plates and bone screws for internal fixation of the femur and tibia. Plate shapes and sizes are matched to these anatomical regions, with locking and cortical screws available in different diameters and lengths.
The implants are made from AISI 316LVM stainless steel. Plates bridge and stabilize the treated bone while screws secure the construct for fractures, osteotomies, malunions or nonunions.
Listed Item
JPS SS 3.5MM Proximal Femur Plate 100° – 3 Holes 12MM Offset Sterile
Patients and Surgical Instruments
The system is intended for pediatric patients other than newborns and for adults of small stature. Implants are offered in sterile and nonsterile packaging. Orthopedic instruments support insertion and removal, with instrument materials selected separately from the implanted plates and screws.
22manufacturers in China registered for this device type
153catalogue numbers in this listing
7510(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 | 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) | K200246 |
| Record published | 2020-07-03 |
| 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 | Lumen/inner diameter 3 to 5 mm; width 156 to 226 mm; angle 80 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 161 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.0 mm | In distribution |
| 1 | Width 202 mm | In distribution |
| 1 | Width 185 mm | In distribution |
| 1 | Width 168 mm | In distribution |
| 1 | In distribution | |
| 1 | Nr of holes: 4 | In distribution |
| 1 | Width 216 mm | In distribution |
| 1 | Width 210 mm | In distribution |
| 1 | Width 194 mm | In distribution |
| 1 | Width 222 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 186 mm | In distribution |
| 1 | Width 166 mm | In distribution |
| 1 | Width 211 mm | In distribution |
| 1 | Width 165 mm | In distribution |
| 1 | Width 164 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 209 mm | In distribution |
| 1 | Width 223 mm | In distribution |
| 1 | Width 173 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 215 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 193 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.0 mm | In distribution |
| 1 | Width 159 mm | In distribution |
| 1 | Width 191 mm | In distribution |
| 1 | Width 157 mm | In distribution |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 178 mm | In distribution |
| 1 | Width 162 mm | In distribution |
| 1 | Width 225 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 167 mm | In distribution |
| 1 | Width 198 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 169 mm | In distribution |
| 1 | Width 200 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 196 mm | In distribution |
| 1 | Width 224 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 226 mm | In distribution |
| 1 | Width 183 mm | In distribution |
| 1 | Width 156 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 171 mm | In distribution |
| 1 | Width 160 mm | In distribution |
| 1 | Width 218 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 195 mm | In distribution |
| 1 | Width 174 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 180 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 184 mm | In distribution |
| 1 | Width 214 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 207 mm | In distribution |
| 1 | Width 175 mm | In distribution |
| 1 | Width 176 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 190 mm | In distribution |
| 1 | Width 188 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 179 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 208 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 197 mm | In distribution |
| 1 | Width 182 mm | In distribution |
| 1 | Width 201 mm | In distribution |
| 1 | Width 170 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 221 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 187 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 172 mm | In distribution |
| 1 | Width 219 mm | In distribution |
| 1 | Width 203 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 189 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 204 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 213 mm | In distribution |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 212 mm | In distribution |
| 1 | Width 181 mm | In distribution |
| 1 | Width 163 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 199 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 205 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1 | Width 158 mm | In distribution |
| 1 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 1 | Width 192 mm | In distribution |
| 1 | Width 177 mm | In distribution |
| 1 | Width 217 mm | In distribution |
| 1 | Width 220 mm | In distribution |
| 1 | Width 206 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.5 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.