GMK Hinge Total Knee System
Fixed tibial tray Right, size 4
7manufacturers in China registered for this device type
74catalogue numbers in this listing
1510(k) clearance
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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K130299 |
| Record published | 2014-11-18 |
| Record revised | 2019-12-11 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.09.4004R | In distribution | |
| 02.09.TA310 | In distribution | |
| 02.09.4005R | In distribution | |
| 02.09.0312H | In distribution | |
| 02.09.0623H | In distribution | |
| 02.09.TA510 | In distribution | |
| 02.09.2606R | In distribution | |
| 02.09.0423H | In distribution | |
| 02.09.4006R | In distribution | |
| 02.09.0223H | In distribution | |
| 02.09.2606L | In distribution | |
| 02.09.0112H | In distribution | |
| 02.09.0512H | In distribution | |
| 02.09.2605L | In distribution | |
| 02.09.2602R | In distribution | |
| 02.09.2603R | In distribution | |
| 02.09.4002R | In distribution | |
| 02.09.2601R | In distribution | |
| 02.09.0614H | In distribution | |
| 02.09.0314H | In distribution | |
| 02.09.0620H | In distribution | |
| 02.09.0617H | In distribution | |
| 02.09.0320H | In distribution | |
| 02.09.4005L | In distribution | |
| 02.09.0220H | In distribution | |
| 02.09.0212H | In distribution | |
| 02.09.0523H | In distribution | |
| 02.09.0217H | In distribution | |
| 02.09.2603L | In distribution | |
| 02.09.0514H | In distribution | |
| 02.09.2601L | In distribution | |
| 02.09.0626H | In distribution | |
| 02.09.TA205 | In distribution | |
| 02.09.TA505 | In distribution | |
| 02.09.0412H | In distribution | |
| 02.09.0120H | In distribution | |
| 02.09.0526H | In distribution | |
| 02.09.0414H | In distribution | |
| 02.09.2602L | In distribution | |
| 02.09.0117H | In distribution | |
| 02.09.2604R | In distribution | |
| 02.09.TA105 | In distribution | |
| 02.09.4002L | In distribution | |
| 02.09.2604L | In distribution | |
| 02.09.0326H | In distribution | |
| 02.09.0123H | In distribution | |
| 02.09.0420H | In distribution | |
| 02.09.TA005 | In distribution | |
| 02.09.TA605 | In distribution | |
| 02.09.TA210 | In distribution | |
| 02.09.2605R | In distribution | |
| 02.09.0517H | In distribution | |
| 02.09.0214H | In distribution | |
| 02.09.0323H | In distribution | |
| 02.09.TA305 | In distribution | |
| 02.09.TA410 | In distribution | |
| 02.09.4003R | In distribution | |
| 02.09.0520H | In distribution | |
| 02.09.0417H | In distribution | |
| 02.09.TA610 | In distribution | |
| 02.09.0126H | In distribution | |
| 02.09.0426H | In distribution | |
| 02.09.4001R | In distribution | |
| 02.09.0317H | In distribution | |
| 02.09.TA010 | In distribution | |
| 02.09.0612H | In distribution | |
| 02.09.TA110 | In distribution | |
| 02.09.4003L | In distribution | |
| 02.09.4004L | In distribution | |
| 02.09.4001L | In distribution | |
| 02.09.TA405 | In distribution | |
| 02.09.0114H | In distribution | |
| 02.09.4006L | In distribution | |
| 02.09.0226H | 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 |
|---|---|
| K130299 | 2013-08-15 |
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|---|
| Medacta Usa Inc | 510(k) number | 2017-05-19 | Class II | Nonconforming Material/Component | One lot of product does not include a screw for attachment to the tibial base plate. | 4 units | 2018-05-29 |
| Medacta Usa Inc | 510(k) number | 2015-04-17 | Class II | Employee error | Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws. | 4 units (US) | 2017-01-05 |
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.