XPE Tibial Insert, PS
The U2 XPE Posteriorly Stabilized Tibial Insert is a polyethylene bearing component for total knee replacement. It is used with the compatible cemented U2 femoral component and tibial tray.…
The U2 XPE Posteriorly Stabilized Tibial Insert is a polyethylene bearing component for total knee replacement. It is used with the compatible cemented U2 femoral component and tibial tray. The insert belongs to the system’s posteriorly stabilized design range.
The bearing is manufactured from irradiated ultra-high molecular weight polyethylene. Manufacturing includes irradiation and melt annealing steps intended to reduce free radicals in the material. The insert’s geometry and size range follow those of the corresponding U2 total knee insert design.
Listed Item
XPE Tibial Insert, PS, #5, 11mm
Patient and Fixation Requirements
The system is intended for cemented use in skeletally mature patients with specified severe knee pain and disability. Salvage after unsuccessful surgery requires satisfactory balance and stability at the time of implantation.
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) | K103733 |
| Record published | 2015-10-24 |
| Record revised | 2022-12-27 (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 |
| Sizes | Height 10 to 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2303-3652 | 11mm | In distribution |
| 2303-3642 | 11mm | In distribution |
| 2303-3643 | 13mm | In distribution |
| 2303-3618 | Height 14 mm | In distribution |
| 2303-3650 | Height 17 mm | In distribution |
| 2303-3636 | Height 10 mm | In distribution |
| 2303-3632 | 11mm | In distribution |
| 2303-3641 | 9mm | In distribution |
| 2303-3637 | #3 | In distribution |
| 2303-3640 | #4 | In distribution |
| 2303-3644 | 15mm | In distribution |
| 2303-3666 | #6 | In distribution |
| 2303-3614 | 15mm | In distribution |
| 2303-3647 | Height 12 mm | In distribution |
| 2303-3623 | 13mm | In distribution |
| 2303-3656 | Height 10 mm | In distribution |
| 2303-3654 | 15mm | In distribution |
| 2303-3628 | #2 | In distribution |
| 2303-3646 | #4 | In distribution |
| 2303-3674 | #7 | In distribution |
| 2303-3660 | #6 | In distribution |
| 2303-3661 | 9mm | In distribution |
| 2303-3655 | 18mm | In distribution |
| 2303-3629 | Height 16 mm | In distribution |
| 2303-3616 | Height 10 mm | In distribution |
| 2303-3667 | Height 12 mm | In distribution |
| 2303-3668 | #6 | In distribution |
| 2303-3620 | #2 | In distribution |
| 2303-3626 | #2 | In distribution |
| 2303-3624 | 15mm | In distribution |
| 2303-3648 | #4 | In distribution |
| 2303-3672 | #7 | In distribution |
| 2303-3669 | Height 16 mm | In distribution |
| 2303-3664 | 15mm | In distribution |
| 2303-3663 | 13mm | In distribution |
| 2303-3662 | 11mm | In distribution |
| 2303-3622 | 11mm | In distribution |
| 2303-3673 | #7 | In distribution |
| 2303-3679 | #7 | In distribution |
| 2303-3675 | #7 | In distribution |
| 2303-3627 | Height 12 mm | In distribution |
| 2303-3653 | 13mm | In distribution |
| 2303-3677 | #7 | In distribution |
| 2303-3657 | #5 | In distribution |
| 2303-3613 | 13mm | In distribution |
| 2303-3649 | Height 16 mm | In distribution |
| 2303-3659 | #5 | In distribution |
| 2303-3619 | #1 | In distribution |
| 2303-3676 | Height 10 mm | In distribution |
| 2303-3638 | Height 14 mm | In distribution |
| 2303-3630 | Height 17 mm | In distribution |
| 2303-3645 | 18mm | In distribution |
| 2303-3634 | 15mm | In distribution |
| 2303-3658 | Height 14 mm | In distribution |
| 2303-3617 | #1 | In distribution |
| 2303-3612 | 11mm | In distribution |
| 2303-3625 | 18mm | In distribution |
| 2303-3678 | Height 14 mm | In distribution |
| 2303-3621 | 9mm | In distribution |
| 2303-3665 | 18mm | In distribution |
| 2303-3670 | Height 17 mm | In distribution |
| 2303-3610 | Height 17 mm | In distribution |
| 2303-3671 | #7 | In distribution |
| 2303-3635 | 18mm | In distribution |
| 2303-3631 | 9mm | In distribution |
| 2303-3615 | 18mm | In distribution |
| 2303-3633 | 13mm | In distribution |
| 2303-3611 | 9mm | In distribution |
| 2303-3651 | 9mm | In distribution |
| 2303-3639 | #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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthopedic Alliance, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 459 units | 2014-03-26 |
| Orthopedic Alliance, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 57 units | 2014-03-26 |
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.