Endo-Model Standard Knee Prosthesis System
Proximal Tibial Spacer,Set Size x-small, consisting of 5, 10 and 15 mm
7manufacturers in China registered for this device type
67catalogue 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) | K821476 |
| Record published | 2015-11-01 |
| 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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-2975/01 | In distribution | |
| 99-0027/11 | In distribution | |
| 15-0027/13 | In distribution | |
| 15-9022/12 | In distribution | |
| 15-8023/25 | In distribution | |
| 15-2519/29 | In distribution | |
| 15-8022/12 | In distribution | |
| 15-3027/13 | In distribution | |
| 16-2011/22 | In distribution | |
| 15-8030/11 | In distribution | |
| 15-0037/14 | In distribution | |
| 15-0027/17 | In distribution | |
| 15-0027/10 | In distribution | |
| 15-9020/12 | In distribution | |
| 15-2516/70 | In distribution | |
| 15-9030/11 | In distribution | |
| 15-2461/11 | In distribution | |
| 16-2015/21 | In distribution | |
| 15-8023/24 | In distribution | |
| 15-0027/33 | In distribution | |
| 99-0027/15 | In distribution | |
| 15-2460/11 | In distribution | |
| 15-0027/14 | In distribution | |
| 15-8024/12 | In distribution | |
| 15-9024/11 | In distribution | |
| 99-0027/12 | In distribution | |
| 15-0037/15 | In distribution | |
| 15-0027/30 | In distribution | |
| 15-0037/16 | In distribution | |
| 15-0027/22 | In distribution | |
| 15-0027/23 | In distribution | |
| 15-8024/11 | In distribution | |
| 15-9024/12 | In distribution | |
| 15-3027/11 | In distribution | |
| 15-3027/10 | In distribution | |
| 15-0027/20 | In distribution | |
| 15-9020/11 | In distribution | |
| 15-0027/11 | In distribution | |
| 15-1027/11 | In distribution | |
| 99-0027/16 | In distribution | |
| 15-2459/12 | In distribution | |
| 15-0027/12 | In distribution | |
| 99-0027/13 | In distribution | |
| 15-2462/11 | In distribution | |
| 15-2517/29 | In distribution | |
| 15-0027/16 | In distribution | |
| 15-0037/17 | In distribution | |
| 15-8030/12 | In distribution | |
| 15-3027/12 | In distribution | |
| 15-0027/31 | In distribution | |
| 15-1027/12 | In distribution | |
| 99-0027/14 | In distribution | |
| 15-0027/21 | In distribution | |
| 15-2460/12 | In distribution | |
| 15-9022/11 | In distribution | |
| 15-2462/12 | In distribution | |
| 15-0027/15 | In distribution | |
| 15-2461/12 | In distribution | |
| 15-1027/10 | In distribution | |
| 15-2516/29 | In distribution | |
| 15-8020/12 | In distribution | |
| 15-0027/32 | In distribution | |
| 15-8020/11 | In distribution | |
| 15-9030/12 | In distribution | |
| 15-8022/11 | In distribution | |
| 15-1027/13 | In distribution | |
| 15-2459/11 | 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
31 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 |
|---|---|---|---|---|---|---|
| Waldemar Link GmbH & Co. KG | UDI-DI | 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 |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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 |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 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 |
| 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 | 5 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 | 4 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 | 7 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 | 5 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 | 5 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 | 5 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 | 5 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 | 5 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 | 3 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 | 5 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 | 3 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 | 3 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 | 5 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 | 5 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 | 8 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 | 5 units |
Recalls
4 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 |
|---|---|---|---|---|
| 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.