Unicondylar Sled Prosthesis
Tibial Component Metal-Backed PE-PorEx
6manufacturers in China registered for this device type
48catalogue 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 | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K152431 |
| Record published | 2016-05-26 |
| Record revised | 2021-09-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-2230/13 | In distribution | |
| 15-2230/08 | In distribution | |
| 15-2030/10 | In distribution | |
| 15-2020/60 | In distribution | |
| 15-2028/14 | In distribution | |
| 15-2028/07 | In distribution | |
| 15-2030/02 | In distribution | |
| 15-2220/52 | In distribution | |
| 15-2028/02 | In distribution | |
| 15-2230/12 | In distribution | |
| 15-2030/07 | In distribution | |
| 15-2030/08 | In distribution | |
| 15-2030/06 | In distribution | |
| 15-2028/04 | In distribution | |
| 15-2030/13 | In distribution | |
| 15-2028/06 | In distribution | |
| 15-2030/03 | In distribution | |
| 15-2030/12 | In distribution | |
| 15-2028/13 | In distribution | |
| 15-2028/09 | In distribution | |
| 15-2028/12 | In distribution | |
| 15-2230/04 | In distribution | |
| 15-2230/11 | In distribution | |
| 15-2020/52 | In distribution | |
| 15-2230/06 | In distribution | |
| 15-2020/40 | In distribution | |
| 15-2230/03 | In distribution | |
| 15-2220/46 | In distribution | |
| 15-2028/08 | In distribution | |
| 15-2028/03 | In distribution | |
| 15-2230/10 | In distribution | |
| 15-2030/11 | In distribution | |
| 15-2230/15 | In distribution | |
| 15-2230/02 | In distribution | |
| 15-2028/16 | In distribution | |
| 15-2230/14 | In distribution | |
| 15-2220/40 | In distribution | |
| 15-2020/46 | In distribution | |
| 15-2028/05 | In distribution | |
| 15-2030/14 | In distribution | |
| 15-2030/04 | In distribution | |
| 15-2220/60 | In distribution | |
| 15-2028/15 | In distribution | |
| 15-2028/10 | In distribution | |
| 15-2230/07 | In distribution | |
| 15-2028/11 | In distribution | |
| 15-2030/15 | In distribution | |
| 15-2028/01 | 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
Recalls Naming This Product
48 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 18 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 17 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 12 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 13 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 13 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 19 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 15 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 19 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 24 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 12 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 13 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 15 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 18 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 15 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 15 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 18 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 17 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 15 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 16 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 20 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 12 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 20 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 15 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 13 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 14 units |
| LinkBio Corp. | 510(k) number | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 16 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 5 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 4 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 7 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 5 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 5 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 5 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 5 units |
| LinkBio Corp. | UDI-DI | 2023-03-21 | Class II | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the imp | 5 units |
Showing 40 of 48.
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.