JTS Extendible Distal Femoral Implant
Rotating Hinge Polyethylene Reamer: Extra-Small
7manufacturers in China registered for this device type
78catalogue numbers in this listing
2510(k) clearances naming this product code
9recalls 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 | Onkos Surgical, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K133152 |
| Record published | 2024-07-19 |
| Record revised | 2026-02-09 (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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| tmktp/ExSm10 | In distribution | |
| tmktp/ExSm5 | In distribution | |
| mktp/Std20 | 20 millimeter | In distribution |
| Smbpr00 | Extra Small | In distribution |
| SMCIC01 | In distribution | |
| imtprhp/Sm | In distribution | |
| imtrrhm/Std | In distribution | |
| imbc/Std | In distribution | |
| tmktp/ExSm15 | In distribution | |
| imtprhp/Std | In distribution | |
| impbimp/ExSm | In distribution | |
| imostme/15 | In distribution | |
| SMCAP01 | Extra Small | In distribution |
| tmktp/Std5 | In distribution | |
| SMMLTB02 | Standard | In distribution |
| imtibjig/prg | In distribution | |
| mktp/Sm5 | 5 millimeter | In distribution |
| imham | In distribution | |
| JTSDF-L-XSM | Extra Small | In distribution |
| mktp/Std5 | 5 millimeter | In distribution |
| mktp/Std15 | Standard | In distribution |
| tckaxl/Sm | In distribution | |
| tckaxl/Std | In distribution | |
| imtibjig/rod | In distribution | |
| JTSDF-R-STD | Standard | In distribution |
| imtrrhm/ExSm | In distribution | |
| imtrrhp/ExSm | In distribution | |
| imtprhp/ExSm | In distribution | |
| SMTBC00G | Extra Small | In distribution |
| tmktp/Std15 | In distribution | |
| Smbpr02 | Standard | In distribution |
| Smbpr01 | Small | In distribution |
| tmktp/Sm20 | In distribution | |
| ibnpin | In distribution | |
| tmktp/Sm5 | In distribution | |
| mktp/Sm20 | 20 millimeters | In distribution |
| JTSDF-R-SM | Small | In distribution |
| imtprmfh/Sm | In distribution | |
| imtprmfh/ExSm | In distribution | |
| mktp/Std10 | Standard | In distribution |
| SMTBC02G | Standard | In distribution |
| mktp/Sm15 | 15 millimeters | In distribution |
| impbimp/Std | In distribution | |
| imtrrhp/Std | In distribution | |
| imtibjig/Rst | In distribution | |
| imtprmfh/Std | In distribution | |
| impbimp/Sm | In distribution | |
| JTSDF-L-STD | Standard | In distribution |
| tmktp/Std10 | In distribution | |
| imgenimp | In distribution | |
| tckaxl/ExSm | In distribution | |
| Smbsh02 | Standard | In distribution |
| Smbsh00 | Extra Small | In distribution |
| JTSDF-L-SM | Small | In distribution |
| Smbsh01 | Small | In distribution |
| SMLTBC00 | Extra Small | In distribution |
| SMMLTB01 | Small | In distribution |
| imcirpr | In distribution | |
| imbc/nut | In distribution | |
| SMMLTBC00-MK3 | In distribution | |
| MLE3 | In distribution | |
| imtrrhm/Sm | In distribution | |
| tmktp/Sm10 | In distribution | |
| imtrfh | In distribution | |
| mktp/Sm10 | 10 millimeter | In distribution |
| imaxcp | In distribution | |
| SMLTBC02 | Standard | In distribution |
| imardrl | In distribution | |
| imtrrhp/Sm | In distribution | |
| tmktp/Sm15 | In distribution | |
| ictjigsh | In distribution | |
| imbc/ExSm | In distribution | |
| SMTBC01G | Small | In distribution |
| tmktp/ExSm20 | In distribution | |
| tmktp/Std20 | In distribution | |
| imbc/Sm | In distribution | |
| JTSDF-R-XSM | Extra Small | In distribution |
| SMLTBC01 | Small | 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 |
|---|---|
| K211677 | 2021-07-28 |
| K161520 | 2016-10-28 |
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
9 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 |
|---|---|---|---|---|---|
| 2024-09-22 | Class II | Nonconforming Material/Component | Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. | 24 units | |
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 99 units | |
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 77 units | |
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 49 units | |
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 120 units | |
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 147 units | |
| 2017-05-23 | Class II | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 4 units | 2018-06-27 |
| 2017-05-23 | Class II | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 4 units | 2018-06-27 |
| 2017-05-23 | Class II | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 4 units | 2018-06-27 |
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.