U2 Femoral Component, CR, Cemented
The U2 CR cemented femoral component replaces the joint surface at the lower end of the femur during knee replacement. It is a single-use implant within United Orthopedic's U2 Total Knee…
The U2 CR cemented femoral component replaces the joint surface at the lower end of the femur during knee replacement. It is a single-use implant within United Orthopedic’s U2 Total Knee System.
The component is cast from cobalt-chromium-molybdenum alloy and fixed to the femur using bone cement. Left and right configurations are available, with proportional sizes that include the size 7 component.
Listed Item
U2 Femoral component, CR, cemented, #7, right
Role in Knee Replacement
The femoral component forms the upper bearing surface of the reconstructed knee. Its selection is part of a total knee procedure for a damaged, painful joint, including primary replacement and selected salvage procedures. This component is intended for cemented fixation.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K140073 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-13 (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 |
|---|---|---|
| 2103-1320 | #2 | In distribution |
| 2103-1470 | #7 | In distribution |
| 2103-1410 | #1 | In distribution |
| 2103-1330 | #3 | In distribution |
| 2103-1310 | #1 | In distribution |
| 2103-1370 | #7 | In distribution |
| 2103-1340 | #4 | In distribution |
| 2103-1350 | #5 | In distribution |
| 2103-1450 | #5 | In distribution |
| 2103-1360 | #6 | In distribution |
| 2103-1420 | #2 | In distribution |
| 2103-1460 | #6 | In distribution |
| 2103-1440 | #4 | In distribution |
| 2103-1430 | #3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252725 | 2025-09-25 |
| K243024 | 2024-12-20 |
| K222700 | 2022-10-06 |
| K210961 | 2021-04-21 |
| K161705 | 2017-03-16 |
| K161360 | 2017-02-01 |
| K152430 | 2016-04-12 |
| K150829 | 2015-09-25 |
| K140073 | 2014-06-16 |
| K132752 | 2014-03-13 |
| K131864 | 2014-01-15 |
| K131116 | 2013-10-30 |
| K122183 | 2013-02-05 |
| K120507 | 2012-05-04 |
| K103733 | 2011-08-02 |
| K100981 | 2010-06-14 |
| K082424 | 2008-12-16 |
| K082469 | 2008-09-26 |
| K051640 | 2006-03-01 |
| K021657 | 2002-08-12 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2026-05-20 | Class II | Process design | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | 2 | |
| 2017-11-24 | Class II | Labeling mix-ups | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. | 14 pieces | 2018-10-09 |
| 2017-11-24 | Class II | Labeling mix-ups | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. | 69 pieces | 2018-10-09 |
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.