AS Univation® XF
AS Univation XF Femur Cemented F5 RM
10manufacturers in China registered for this device type
22catalogue numbers in this listing
8recalls on this code
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 | Aesculap AG, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 7) |
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 | 2024-05-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NO184Z | Implant Fixation : cemented | Withdrawn |
| NO157Z | Implant Fixation : cemented | Withdrawn |
| NO161Z | Anatomic Term : right medial | Withdrawn |
| NO156Z | Anatomic Term : right medial | Withdrawn |
| NO167Z | Implant Fixation : cemented | Withdrawn |
| NO160Z | Implant Fixation : cemented | Withdrawn |
| NO181Z | Implant Fixation : cemented | Withdrawn |
| NO165Z | Implant Fixation : cemented | Withdrawn |
| NO159Z | Anatomic Term : right medial | Withdrawn |
| NO162Z | Implant Fixation : cemented | Withdrawn |
| NO185Z | Implant Fixation : cemented | Withdrawn |
| NO166Z | Implant Fixation : cemented | Withdrawn |
| NO183Z | Implant Fixation : cemented | Withdrawn |
| NO158Z | Implant Fixation : cemented | Withdrawn |
| NO189Z | Implant Fixation : cemented | Withdrawn |
| NO180Z | Implant Fixation : cemented | Withdrawn |
| NO187Z | Implant Fixation : cemented | Withdrawn |
| NO186Z | Implant Fixation : cemented | Withdrawn |
| NO164Z | Anatomic Term : left medial | Withdrawn |
| NO188Z | Implant Fixation : cemented | Withdrawn |
| NO163Z | Implant Fixation : cemented | Withdrawn |
| NO182Z | Implant Fixation : cemented | 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 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| 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 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Recalls
8 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 | Closed |
|---|---|---|---|---|
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
| 2021-03-19 | Class II | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery | 2025-03-28 |
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.