AS
AS Femur Extens.stem 5° D16X117 Cem.less
7manufacturers in China registered for this device type
69catalogue numbers in this listing
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 5) |
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 |
| Distribution end date | 2025-01-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NR406Z | Length : 117.000 MM | Withdrawn |
| NR172Z | Implant Fixation : cementless | Withdrawn |
| NR534Z | Diameter (mm) : 14.000 MM | Withdrawn |
| NR494Z | Implant Fixation : cementless | Withdrawn |
| NR539Z | Implant Fixation : cementless | Withdrawn |
| NR538Z | Diameter (mm) : 18.000 MM | Withdrawn |
| NR436Z | Diameter (mm) : 16.000 MM | Withdrawn |
| NR192Z | Diameter (mm) : 15.000 MM | Withdrawn |
| NR532Z | Implant Fixation : cementless | Withdrawn |
| NR195Z | Implant Fixation : cemented | Withdrawn |
| NR536Z | Implant Fixation : cementless | Withdrawn |
| NR504Z | Diameter (mm) : 14.000 MM | Withdrawn |
| NR440Z | Diameter (mm) : 20.000 MM | Withdrawn |
| NR400Z | Implant Fixation : cemented and cementless | Withdrawn |
| NR180Z | Length : 92.000 MM | Withdrawn |
| NR502Z | Length : 117.000 MM | Withdrawn |
| NR438Z | Diameter (mm) : 18.000 MM | Withdrawn |
| NR177Z | Figure/Size : Size M | Withdrawn |
| NR499Z | Diameter (mm) : 19.000 MM | Withdrawn |
| NR498Z | Length : 172.000 MM | Withdrawn |
| NR171Z | Implant Fixation : cementless | Withdrawn |
| NR196Z | Implant Fixation : cemented | Withdrawn |
| NR439Z | Diameter (mm) : 19.000 MM | Withdrawn |
| NR509Z | Implant Fixation : cementless | Withdrawn |
| NR293Z | Length : 77.000 MM | Withdrawn |
| NR402Z | Length : 117.000 MM | Withdrawn |
| NR497Z | Length : 172.000 MM | Withdrawn |
| NR294Z | Length : 157.000 MM | Withdrawn |
| NR179Z | Implant Fixation : cementless | Withdrawn |
| NR537Z | Implant Fixation : cementless | Withdrawn |
| NR191Z | Diameter (mm) : 12.000 MM | Withdrawn |
| NR409Z | Implant Fixation : cementless | Withdrawn |
| NR291Z | Implant Fixation : cemented | Withdrawn |
| NR510Z | Length : 117.000 MM | Withdrawn |
| NR495Z | Implant Fixation : cementless | Withdrawn |
| NR492Z | Length : 172.000 MM | Withdrawn |
| NR410Z | Length : 117.000 MM | Withdrawn |
| NR435Z | Length : 177.000 MM | Withdrawn |
| NR496Z | Diameter (mm) : 16.000 MM | Withdrawn |
| NR493Z | Implant Fixation : cementless | Withdrawn |
| NR292Z | Implant Fixation : cemented | Withdrawn |
| NR507Z | Length : 117.000 MM | Withdrawn |
| NR174Z | Diameter (mm) : 14.000 MM | Withdrawn |
| NR503Z | Implant Fixation : cementless | Withdrawn |
| NR404Z | Implant Fixation : cementless | Withdrawn |
| NR432Z | Implant Fixation : cementless | Withdrawn |
| NR408Z | Diameter (mm) : 18.000 MM | Withdrawn |
| NR433Z | Diameter (mm) : 13.000 MM | Withdrawn |
| NR178Z | Diameter (mm) : 18.000 MM | Withdrawn |
| NR535Z | Implant Fixation : cementless | Withdrawn |
| NR173Z | Length : 92.000 MM | Withdrawn |
| NR176Z | Implant Fixation : cementless | Withdrawn |
| NR505Z | Diameter (mm) : 15.000 MM | Withdrawn |
| NR500Z | Diameter (mm) : 20.000 MM | Withdrawn |
| NR437Z | Diameter (mm) : 17.000 MM | Withdrawn |
| NR506Z | Implant Fixation : cementless | Withdrawn |
| NR194Z | Diameter (mm) : 12.000 MM | Withdrawn |
| NR508Z | Length : 117.000 MM | Withdrawn |
| NR193Z | Length : 52.000 MM | Withdrawn |
| NR405Z | Implant Fixation : cementless | Withdrawn |
| NR407Z | Diameter (mm) : 17.000 MM | Withdrawn |
| NR175Z | Length : 92.000 MM | Withdrawn |
| NR491Z | Length : 172.000 MM | Withdrawn |
| NR434Z | Diameter (mm) : 14.000 MM | Withdrawn |
| NR296Z | Diameter (mm) : 18.000 MM | Withdrawn |
| NR403Z | Diameter (mm) : 13.000 MM | Withdrawn |
| NR295Z | Diameter (mm) : 15.000 MM | Withdrawn |
| NR533Z | Diameter (mm) : 13.000 MM | Withdrawn |
| NR540Z | Length : 177.000 MM | 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
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.