Link Endo-Model EVO
Modular Stem, Conical Cemented Stem, 3 mm Offset
7manufacturers in China registered for this device type
92catalogue numbers in this listing
5510(k) clearances naming this product code
19recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| 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 |
|---|---|---|
| 15-2951/63 | In distribution | |
| 15-3950/27 | In distribution | |
| 15-2954/02 | In distribution | |
| 15-4613/08 | In distribution | |
| 15-4302/16 | In distribution | |
| 15-2950/15 | In distribution | |
| 15-4313/08 | In distribution | |
| 15-4616/16 | In distribution | |
| 15-4312/12 | In distribution | |
| 15-4613/12 | In distribution | |
| 15-3950/41 | In distribution | |
| 15-2953/00 | In distribution | |
| 15-2953/01 | In distribution | |
| 15-2951/66 | In distribution | |
| 15-3950/32 | In distribution | |
| 15-2951/60 | In distribution | |
| 15-2951/64 | In distribution | |
| 15-4305/08 | In distribution | |
| 15-3950/15 | In distribution | |
| 15-2950/13 | In distribution | |
| 15-3950/25 | In distribution | |
| 15-2951/47 | In distribution | |
| 15-5305/16 | In distribution | |
| 15-2951/56 | In distribution | |
| 15-4614/16 | In distribution | |
| 15-3950/43 | In distribution | |
| 15-3950/28 | In distribution | |
| 15-5605/16 | In distribution | |
| 15-4616/08 | In distribution | |
| 15-2975/18 | In distribution | |
| 15-2958/10 | In distribution | |
| 15-4612/12 | In distribution | |
| 15-6118/29 | In distribution | |
| 15-4605/24 | In distribution | |
| 15-2950/32 | In distribution | |
| 15-3950/36 | In distribution | |
| 15-4311/08 | In distribution | |
| 15-4319/16 | In distribution | |
| 15-4614/08 | In distribution | |
| 15-4605/18 | In distribution | |
| 15-3950/29 | In distribution | |
| 15-5302/16 | In distribution | |
| 15-5604/12 | In distribution | |
| 15-4617/16 | In distribution | |
| 15-2951/55 | In distribution | |
| 15-2950/45 | In distribution | |
| 15-5306/16 | In distribution | |
| 15-4304/24 | In distribution | |
| 15-4320/12 | In distribution | |
| 15-4310/12 | In distribution | |
| 15-3950/22 | In distribution | |
| 15-2958/07 | In distribution | |
| 15-4606/08 | In distribution | |
| 15-2951/79 | In distribution | |
| 15-2954/00 | In distribution | |
| 15-4611/16 | In distribution | |
| 15-4604/18 | In distribution | |
| 15-5604/24 | In distribution | |
| 15-2951/91 | In distribution | |
| 15-2953/08 | In distribution | |
| 15-4620/16 | In distribution | |
| 15-5306/24 | In distribution | |
| 15-5604/08 | In distribution | |
| 15-2958/02 | In distribution | |
| 15-3950/30 | In distribution | |
| 15-5304/24 | In distribution | |
| 15-2951/44 | In distribution | |
| 15-4312/16 | In distribution | |
| 15-4318/16 | In distribution | |
| 15-4619/16 | In distribution | |
| 15-4305/16 | In distribution | |
| 15-2958/12 | In distribution | |
| 15-2958/09 | In distribution | |
| 15-5302/08 | In distribution | |
| 15-5604/16 | In distribution | |
| 15-4606/18 | In distribution | |
| 15-2950/29 | In distribution | |
| 15-2954/10 | In distribution | |
| 15-3950/24 | In distribution | |
| 15-2950/23 | In distribution | |
| 15-2950/42 | In distribution | |
| 15-5606/18 | In distribution | |
| 15-4311/16 | In distribution | |
| 15-4605/08 | In distribution | |
| 15-2950/24 | In distribution | |
| 15-5605/24 | In distribution | |
| 15-2950/14 | In distribution | |
| 15-2950/21 | In distribution | |
| 15-5306/08 | In distribution | |
| 15-4317/08 | In distribution | |
| 15-3950/17 | In distribution | |
| 15-2953/10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220628 | 2022-05-03 |
| K211768 | 2021-06-30 |
| K152431 | 2016-05-09 |
| K151008 | 2015-08-26 |
| K143179 | 2015-01-30 |
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 |
Recalls
19 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-07-06 | Class II | Process change control | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative | 1 US; 9 OUS |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 44 units (1 US, 43 OUS) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 4 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 3 units |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 49 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 7 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 4 units (all OUS) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 3 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 8 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 31 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 1 unit (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 2 units (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 1 unit (OUS only) |
| 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 7 units (OUS only) |
| 2025-11-10 | Class II | Process control | The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. | 18 units |
| 2021-03-18 | Class II | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. | 21 units |
| 2021-03-18 | Class II | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. | 13 units |
| 2021-03-18 | Class II | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. | 16 units |
| 2021-03-18 | Class II | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. | 22 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.