LinkSymphoKnee
201 catalogue numbers from 880-081/45, listed by Waldemar Link GmbH & Co. KG, Germany, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
201catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), 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 |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | 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 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K202924 |
| Record published | 2021-10-07 |
| Record revised | 2023-09-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-06-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 880-081/45 | In distribution | |
| 880-621/13 | In distribution | |
| 880-618/22 | In distribution | |
| 880-241/12 | In distribution | |
| 880-511/40 | In distribution | |
| 881-119/30 | In distribution | |
| 880-031/45 | In distribution | |
| 880-081/50 | In distribution | |
| 880-020/45 | In distribution | |
| 880-235/16 | In distribution | |
| 880-264/12 | In distribution | |
| 880-232/22 | In distribution | |
| 880-021/20 | In distribution | |
| 880-233/22 | In distribution | |
| 880-234/18 | In distribution | |
| 880-239/20 | In distribution | |
| 880-225/12 | In distribution | |
| 880-021/70 | In distribution | |
| 880-229/16 | In distribution | |
| 880-214/14 | In distribution | |
| 880-331/13 | In distribution | |
| 880-254/11 | In distribution | |
| 880-415/12 | In distribution | |
| 880-303/11 | In distribution | |
| 880-275/16 | In distribution | |
| 880-235/24 | In distribution | |
| 880-010/20 | In distribution | |
| 881-114/78 | In distribution | |
| 880-628/16 | In distribution | |
| 880-607/12 | In distribution | |
| 880-327/13 | In distribution | |
| 880-337/23 | In distribution | |
| 880-625/16 | In distribution | |
| 880-234/16 | In distribution | |
| 881-113/70 | In distribution | |
| 880-253/16 | In distribution | |
| 880-209/12 | In distribution | |
| 880-217/10 | In distribution | |
| 880-011/30 | In distribution | |
| 880-274/10 | In distribution | |
| 880-237/20 | In distribution | |
| 880-212/16 | In distribution | |
| 880-211/18 | In distribution | |
| 880-603/20 | In distribution | |
| 880-040/60 | In distribution | |
| 880-601/18 | In distribution | |
| 880-251/16 | In distribution | |
| 880-601/16 | In distribution | |
| 880-232/14 | In distribution | |
| 880-070/00 | In distribution | |
| 880-611/17 | In distribution | |
| 880-060/50 | In distribution | |
| 880-310/21 | In distribution | |
| 880-337/21 | In distribution | |
| 880-628/22 | In distribution | |
| 880-211/12 | In distribution | |
| 880-205/14 | In distribution | |
| 880-303/21 | In distribution | |
| 880-613/12 | In distribution | |
| 880-207/10 | In distribution | |
| 880-41X/12 | In distribution | |
| 880-011/70 | In distribution | |
| 880-211/16 | In distribution | |
| 880-265/14 | In distribution | |
| 880-618/20 | In distribution | |
| 880-021/55 | In distribution | |
| 880-223/11 | In distribution | |
| 880-339/22 | In distribution | |
| 880-417/11 | In distribution | |
| 880-209/18 | In distribution | |
| 880-261/11 | In distribution | |
| 880-233/18 | In distribution | |
| 880-040/X0 | In distribution | |
| 880-412/22 | In distribution | |
| 880-235/20 | In distribution | |
| 880-603/11 | In distribution | |
| 880-011/90 | In distribution | |
| 880-413/23 | In distribution | |
| 880-623/10 | In distribution | |
| 881-114/02 | In distribution | |
| 880-213/10 | In distribution | |
| 880-411/13 | In distribution | |
| 880-323/13 | In distribution | |
| 880-031/35 | In distribution | |
| 880-061/50 | In distribution | |
| 880-217/14 | In distribution | |
| 880-605/12 | In distribution | |
| 880-080/00 | In distribution | |
| 880-070/20 | In distribution | |
| 880-100/90 | In distribution | |
| 880-233/14 | In distribution | |
| 880-273/24 | In distribution | |
| 880-080/80 | In distribution | |
| 880-625/15 | In distribution | |
| 880-070/55 | In distribution | |
| 880-605/13 | In distribution | |
| 880-249/16 | In distribution | |
| 880-418/13 | In distribution | |
| 881-113/60 | In distribution | |
| 880-414/12 | In distribution | |
| 881-113/30 | In distribution | |
| 881-113/20 | In distribution | |
| 880-271/18 | In distribution | |
| 880-040/10 | In distribution | |
| 880-207/12 | In distribution | |
| 880-011/35 | In distribution | |
| 880-623/19 | In distribution | |
| 880-628/20 | In distribution | |
| 880-627/18 | In distribution | |
| 880-279/10 | In distribution | |
| 880-279/12 | In distribution | |
| 880-317/12 | In distribution | |
| 880-201/12 | In distribution | |
| 880-205/18 | In distribution | |
| 880-601/17 | In distribution | |
| 880-605/16 | In distribution | |
| 880-080/35 | In distribution | |
| 880-275/24 | In distribution | |
| 880-305/22 | In distribution | |
| 880-262/14 | In distribution | |
| 880-629/20 | In distribution | |
| 880-100/80 | In distribution | |
| 880-269/10 | In distribution | |
| 880-224/12 | In distribution | |
| 880-060/70 | In distribution | |
| 880-412/23 | In distribution | |
| 880-209/16 | In distribution | |
| 880-212/14 | In distribution | |
| 880-232/20 | In distribution | |
| 880-212/12 | In distribution | |
| 880-252/11 | In distribution | |
| 880-305/11 | In distribution | |
| 881-119/10 | In distribution | |
| 880-273/22 | In distribution | |
| 880-241/10 | In distribution | |
| 880-011/40 | In distribution | |
| 880-235/10 | In distribution | |
| 880-030/30 | In distribution | |
| 880-271/14 | In distribution | |
| 880-511/34 | In distribution | |
| 880-254/10 | In distribution | |
| 880-613/19 | In distribution | |
| 880-232/16 | In distribution | |
| 880-090/X0 | In distribution | |
| 880-214/11 | In distribution | |
| 880-313/21 | In distribution | |
| 880-231/14 | In distribution | |
| 880-621/14 | In distribution | |
| 880-319/21 | In distribution | |
| 880-255/16 | In distribution | |
| 880-262/18 | In distribution | |
| 880-100/X0 | In distribution | |
| 881-113/40 | In distribution | |
| 880-621/15 | In distribution | |
| 880-625/17 | In distribution | |
| 880-613/17 | In distribution | |
| 880-010/30 | In distribution | |
| 880-020/30 | In distribution | |
| 880-611/15 | In distribution | |
| 880-071/30 | In distribution | |
| 880-080/40 | In distribution | |
| 880-020/40 | In distribution | |
| 881-210/03 | In distribution | |
| 880-060/30 | In distribution | |
| 880-040/80 | In distribution | |
| 880-233/24 | In distribution | |
| 880-217/18 | In distribution | |
| 880-232/18 | In distribution | |
| 880-070/45 | In distribution | |
| 880-090/80 | In distribution | |
| 880-040/70 | In distribution | |
| 880-020/00 | In distribution | |
| 880-331/23 | In distribution | |
| 880-241/11 | In distribution | |
| 880-011/60 | In distribution | |
| 880-252/10 | In distribution | |
| 880-333/12 | In distribution | |
| 880-331/22 | In distribution | |
| 880-273/20 | In distribution | |
| 880-239/24 | In distribution | |
| 880-262/10 | In distribution | |
| 880-203/16 | In distribution | |
| 880-279/18 | In distribution | |
| 880-081/20 | In distribution | |
| 880-050/X0 | In distribution | |
| 880-254/16 | In distribution | |
| 880-031/20 | In distribution | |
| 880-071/40 | In distribution | |
| 880-253/11 | In distribution | |
| 880-323/23 | In distribution | |
| 880-267/10 | In distribution | |
| 880-269/16 | In distribution | |
| 880-255/12 | In distribution | |
| 880-305/12 | In distribution | |
| 880-232/10 | In distribution | |
| 881-115/20 | In distribution | |
| 881-159/00 | In distribution | |
| 880-275/18 | In distribution | |
| 880-608/18 | In distribution | |
| ET18221 | Withdrawn | |
| ET18220 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
| Restoris | Mako Surgical Corp. | 118 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.