Link Endo-Model EVO
Modular Stem, Conical Cemented Stem, 6 mm Offset
6manufacturers in China registered for this device type
69catalogue 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) | K202924 |
| Record published | 2021-10-07 |
| Record revised | 2025-06-09 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-4611/08 | In distribution | |
| 15-4602/12 | In distribution | |
| 15-4616/12 | In distribution | |
| 15-2951/68 | In distribution | |
| 15-2951/74 | In distribution | |
| 15-4314/12 | In distribution | |
| 15-2954/03 | In distribution | |
| 15-6118/30 | In distribution | |
| 15-4606/16 | In distribution | |
| 15-4610/08 | In distribution | |
| 15-4304/08 | In distribution | |
| 15-3950/12 | In distribution | |
| 15-4305/18 | In distribution | |
| 15-4310/08 | In distribution | |
| 15-2951/45 | In distribution | |
| 15-2951/58 | In distribution | |
| 15-2954/08 | In distribution | |
| 15-4610/12 | In distribution | |
| 15-2950/28 | In distribution | |
| 15-4306/16 | In distribution | |
| 15-5606/16 | In distribution | |
| 15-2953/02 | In distribution | |
| 15-2951/81 | In distribution | |
| 15-3950/19 | In distribution | |
| 15-4604/12 | In distribution | |
| 15-5305/08 | In distribution | |
| 15-3950/38 | In distribution | |
| 15-4319/12 | In distribution | |
| 15-3950/21 | In distribution | |
| 15-2954/11 | In distribution | |
| 15-4612/08 | In distribution | |
| 15-4604/08 | In distribution | |
| 15-4314/16 | In distribution | |
| 15-3950/42 | In distribution | |
| 15-4618/12 | In distribution | |
| 15-2951/49 | In distribution | |
| 15-2958/03 | In distribution | |
| 15-3950/40 | In distribution | |
| 15-3950/20 | In distribution | |
| 15-2950/37 | In distribution | |
| 15-4605/16 | In distribution | |
| 15-2950/44 | In distribution | |
| 15-3950/14 | In distribution | |
| 15-2950/41 | In distribution | |
| 15-4604/16 | In distribution | |
| 15-4306/12 | In distribution | |
| 15-5305/18 | In distribution | |
| 15-4620/12 | In distribution | |
| 15-2953/03 | In distribution | |
| 15-2975/22 | In distribution | |
| 15-5304/18 | In distribution | |
| 15-2950/20 | In distribution | |
| 15-3950/44 | In distribution | |
| 15-4313/16 | In distribution | |
| 15-3950/39 | In distribution | |
| 15-2951/48 | In distribution | |
| 15-2951/90 | In distribution | |
| 15-2950/19 | In distribution | |
| 15-2951/92 | In distribution | |
| 15-4316/12 | In distribution | |
| 15-3950/31 | In distribution | |
| 15-2950/22 | In distribution | |
| 15-3950/46 | In distribution | |
| 15-2950/16 | In distribution | |
| 15-3950/33 | In distribution | |
| 15-4317/16 | In distribution | |
| 15-4304/16 | In distribution | |
| 15-5302/12 | In distribution | |
| 15-2951/75 | 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
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-07-31 | Class II | Under Investigation by firm | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. | 8 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 1180 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 908 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 441 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 1771 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-02-14 | Class II | Labeling Change Control | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | 37 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-02-14 | Class II | Labeling Change Control | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | 52 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-02-14 | Class II | Labeling Change Control | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | 20 units |
| LinkBio Corp. | 510(k) number | 2023-04-25 | Class II | Under Investigation by firm | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left). | 11 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2022-12-23 | Class II | Component change control | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). | 20 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2022-12-23 | Class II | Component change control | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). | 20 units |
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.