Contours Lapidus Plating System
Contours Lapidus combines plates and screws for revision procedures and joint fusion in small foot bones. Left and right plates are low-profile and contoured for the first metatarsal and…
Contours Lapidus combines plates and screws for revision procedures and joint fusion in small foot bones. Left and right plates are low-profile and contoured for the first metatarsal and cuneiform.
Each plate has a trapezoidal screw-hole pattern with three angled, threaded holes at each end. A separate compression hole supports compression across the joint, while screws fix the plate to bone.
Listed Item
Screw, Lapidus, 3.5MM X 1.25 X 28MM W/4.5MM X 7.5 Locking
Fastener and Supply Options
Plates and screws are Ti-6Al-4V ELI titanium alloy. The screw range includes low-profile locking, nonlocking and compression designs, with lengths varying by screw type. Manual instruments accompany the system, and components are supplied nonsterile for sterilization before 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) | K102201 |
| Record published | 2018-04-19 |
| Record revised | 2025-10-24 (version 9) |
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, manufacturing date |
| Sizes | Width 119 to 262 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | Width 237 mm | In distribution |
| 1 | Width 249 mm | In distribution |
| 1 | Width 248 mm | In distribution |
| 1 | Width 238 mm | In distribution |
| 1 | Width 231 mm | In distribution |
| 1 | Width 235 mm | In distribution |
| 1 | Width 228 mm | In distribution |
| 1 | Width 255 mm | In distribution |
| 1 | Width 230 mm | In distribution |
| 1 | Width 258 mm | In distribution |
| 1 | Width 261 mm | In distribution |
| 1 | Width 214 mm | In distribution |
| 1 | Width 226 mm | In distribution |
| 1 | Width 257 mm | In distribution |
| 1 | Width 244 mm | In distribution |
| 1 | Width 212 mm | In distribution |
| 1 | Width 229 mm | In distribution |
| 1 | Width 243 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 213 mm | In distribution |
| 1 | Width 250 mm | In distribution |
| 1 | Width 236 mm | In distribution |
| 1 | Width 259 mm | In distribution |
| 1 | Width 233 mm | In distribution |
| 1 | Width 240 mm | In distribution |
| 1 | Width 246 mm | In distribution |
| 1 | Width 262 mm | In distribution |
| 1 | Width 232 mm | In distribution |
| 1 | Width 242 mm | In distribution |
| 1 | Width 234 mm | In distribution |
| 1 | Width 247 mm | In distribution |
| 1 | Width 245 mm | In distribution |
| 1 | Width 215 mm | In distribution |
| 1 | Width 252 mm | In distribution |
| 1 | Width 225 mm | In distribution |
| 1 | Width 119 mm | In distribution |
| 1 | Width 260 mm | In distribution |
| 1 | Width 211 mm | In distribution |
| 1 | Width 251 mm | In distribution |
| 1 | Width 253 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 254 mm | In distribution |
| 1 | Width 241 mm | In distribution |
| 1 | Width 227 mm | In distribution |
| 1 | Width 256 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.