Ortholoc®
ORTHOLOC® II POST STAB TIBIAL INSERT THICK SM/SM+/SM++ 12mm
6manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-20 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 8 to 20 mm; outer diameter 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18406216 | Height 12 mm | In distribution |
| 18400116 | Height 12 mm | In distribution |
| 18500134 | Height 12 mm | In distribution |
| 18501132 | Height 10 mm | In distribution |
| 18400144 | Height 10 mm | In distribution |
| 18400127 | Height 14 mm | In distribution |
| 18400137 | Height 14 mm | In distribution |
| 18406214 | Height 10 mm | In distribution |
| 18400132 | Height 8 mm | In distribution |
| 18501134 | Height 12 mm | In distribution |
| 18400122 | Height 18 mm | In distribution |
| 18406314 | Height 10 mm | In distribution |
| 18400138 | Height 16 mm | In distribution |
| 18500120 | Height 8 mm | In distribution |
| 18400126 | Height 12 mm | In distribution |
| 18500124 | Height 12 mm | In distribution |
| 18406412 | Height 8 mm | In distribution |
| 18409130 | Height 20 mm | In distribution |
| 18400147 | Height 14 mm | In distribution |
| 18400112 | Height 8 mm | In distribution |
| 18500122 | Height 10 mm | In distribution |
| 18406312 | Height 8 mm | In distribution |
| 18400149 | Height 18 mm | In distribution |
| 18500152 | Height 10 mm | In distribution |
| 18501124 | Height 12 mm | In distribution |
| 18400129 | Height 18 mm | In distribution |
| 18406414 | Height 10 mm | In distribution |
| 18501120 | Height 8 mm | In distribution |
| 18409140 | Height 20 mm | In distribution |
| 18400142 | Height 8 mm | In distribution |
| 18500132 | Height 10 mm | In distribution |
| 18500154 | Height 12 mm | In distribution |
| 18450244 | Outer Diameter 35 mm | In distribution |
| 18406212 | Height 8 mm | In distribution |
| 18409120 | Height 20 mm | In distribution |
| 18400118 | Height 16 mm | In distribution |
| 18400117 | Height 14 mm | In distribution |
| 18400148 | Height 16 mm | In distribution |
| 18500130 | Height 8 mm | In distribution |
| 18409150 | Height 20 mm | In distribution |
| 18400146 | Height 12 mm | In distribution |
| 18501122 | Height 10 mm | In distribution |
| 18400134 | Height 10 mm | In distribution |
| 18406316 | Height 12 mm | In distribution |
| 18400128 | Height 16 mm | In distribution |
| 18406317 | Height 14 mm | In distribution |
| 18406217 | Height 14 mm | In distribution |
| 18400119 | Height 18 mm | In distribution |
| 18501130 | Height 8 mm | In distribution |
| 18400124 | Height 10 mm | In distribution |
| 18400139 | Height 18 mm | In distribution |
| 18406416 | Height 12 mm | In distribution |
| 18400136 | Height 12 mm | In distribution |
| 18406417 | Height 14 mm | In distribution |
| 18400114 | Height 10 mm | In distribution |
| 18500138 | Height 20 mm | In distribution |
| 18450240 | Outer Diameter 35 mm | In distribution |
| 18500150 | Height 8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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.