Stanmore
Tibial Rotating Hinge Metal Cased Bearing XSM
7manufacturers in China registered for this device type
31catalogue numbers in this listing
5510(k) clearances naming this product code
7recalls 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 | Stanmore Implants Worldwide, Ltd., United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| 510(k) | K092138 |
| Record published | 2019-07-18 |
| Record revised | 2023-06-05 (version 3) |
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 |
| Distribution end date | 2023-06-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMTBC00G | Extra Small | Withdrawn |
| mktp/Std10 | Standard | Withdrawn |
| SMLTBC02 | Standard | Withdrawn |
| mktp/Sm20 | Thickness: 20 millimeters | Withdrawn |
| mktp/Sm15 | Thickness: 15 millimeters | Withdrawn |
| JTSDF-L-SM | Small | Withdrawn |
| JTSDF-R-SM | Small | Withdrawn |
| mktp/Std5 | Standard | Withdrawn |
| Smbsh01 | Small | Withdrawn |
| mktp/Sm10 | Thickness: 10 millimeter | Withdrawn |
| JTSDF-L-STD | Standard | Withdrawn |
| SMTBC02G | Standard | Withdrawn |
| SMCIC01 | Withdrawn | |
| SMMLTBC00-MK3 | Extra Small | Withdrawn |
| mktp/Sm5 | Thickness: 5 millimeter | Withdrawn |
| SMLTBC01 | Small | Withdrawn |
| SMMLTB02 | Standard | Withdrawn |
| Smbpr02 | Standard | Withdrawn |
| JTSDF-L-XSM | Extra Small | Withdrawn |
| SMLTBC00 | Extra Small | Withdrawn |
| Smbpr00 | Extra Small | Withdrawn |
| Smbsh02 | Standard | Withdrawn |
| Smbsh00 | Extra Small | Withdrawn |
| SMMLTB01 | Small | Withdrawn |
| JTSDF-R-XSM | Extra Small | Withdrawn |
| mktp/Std15 | Standard | Withdrawn |
| SMCAP01 | Extra Small | Withdrawn |
| SMTBC01G | Small | Withdrawn |
| mktp/Std20 | Thickness: 20 millimeter | Withdrawn |
| Smbpr01 | Small | Withdrawn |
| JTSDF-R-STD | Standard | Withdrawn |
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 |
|---|---|
| K140898 | 2015-01-20 |
| K133152 | 2014-01-22 |
| K121029 | 2012-09-19 |
| K120992 | 2012-09-05 |
| K092138 | 2011-03-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stanmore Implants Worldwide, Ltd. | 510(k) number | 2017-07-04 | Class II | Labeling design | Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings fo | 15 units | 2021-02-16 |
Recalls
6 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 | Closed |
|---|---|---|---|---|---|
| 2016-12-07 | Class II | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device’s stem. | 15 units | 2017-07-17 |
| 2016-12-07 | Class II | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device’s stem. | 15 units | 2017-07-17 |
| 2016-12-07 | Class II | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device’s stem. | 13 units | 2017-07-17 |
| 2016-12-07 | Class II | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device’s stem. | 11 units | 2017-07-17 |
| 2016-12-07 | Class II | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device’s stem. | 51 units | 2017-07-17 |
| 2016-05-31 | Class II | Device Design | The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation. | 3 units | 2017-03-02 |
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.