All Poly Tibial Component, PS
The United Orthopedic all-poly tibial PS component is the polyethylene portion of a total knee replacement that sits on the tibial side of the joint. Its upper bearing surface articulates…
The United Orthopedic all-poly tibial PS component is the polyethylene portion of a total knee replacement that sits on the tibial side of the joint. Its upper bearing surface articulates with a compatible posterior-stabilized femoral component.
This component is made from ultra-high-molecular-weight polyethylene and includes an embedded metal marking wire for identification on X-ray images. PS geometry is intended for a knee construct in which the posterior cruciate ligament is absent or cannot be preserved.
Listed Item
All poly tibial component, PS, #6, 12mm
PS Configuration
The PS range includes sizes 0 through 7 and thicknesses from 9 to 18 mm. It is paired with PS femoral components of the U2 Total Knee System; cruciate-retaining and ultracongruent tibial designs are separate options in the broader all-poly family.
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) | K152430 |
| Record published | 2016-05-06 |
| Record revised | 2018-07-31 (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 |
|---|---|---|
| 2203-1267 | #6 | In distribution |
| 2203-1255 | #5 | In distribution |
| 2203-1252 | #5 | In distribution |
| 2203-1229 | #2 | In distribution |
| 2203-1239 | #3 | In distribution |
| 2203-1279 | #7 | In distribution |
| 2203-1203 | #0 | In distribution |
| 2203-1241 | #4 | In distribution |
| 2203-1234 | #3 | In distribution |
| 2203-1225 | #2 | In distribution |
| 2203-1228 | #2 | In distribution |
| 2203-1243 | #4 | In distribution |
| 2203-1214 | #1 | In distribution |
| 2203-1276 | #7 | In distribution |
| 2203-1264 | #6 | In distribution |
| 2203-1201 | #0 | In distribution |
| 2203-1248 | #4 | In distribution |
| 2203-1247 | #4 | In distribution |
| 2203-1240 | #4 | In distribution |
| 2203-1233 | #3 | In distribution |
| 2203-1272 | #7 | In distribution |
| 2203-1254 | #5 | In distribution |
| 2203-1274 | #7 | In distribution |
| 2203-1211 | #1 | In distribution |
| 2203-1250 | #5 | In distribution |
| 2203-1216 | #1 | In distribution |
| 2203-1215 | #1 | In distribution |
| 2203-1222 | #2 | In distribution |
| 2203-1213 | #1 | In distribution |
| 2203-1258 | #5 | In distribution |
| 2203-1230 | #3 | In distribution |
| 2203-1205 | #0 | In distribution |
| 2203-1261 | #6 | In distribution |
| 2203-1278 | #7 | In distribution |
| 2203-1227 | #2 | In distribution |
| 2203-1275 | #7 | In distribution |
| 2203-1256 | #5 | In distribution |
| 2203-1231 | #3 | In distribution |
| 2203-1218 | #1 | In distribution |
| 2203-1226 | #2 | In distribution |
| 2203-1263 | #6 | In distribution |
| 2203-1224 | #2 | In distribution |
| 2203-1202 | #0 | In distribution |
| 2203-1273 | #7 | In distribution |
| 2203-1236 | #3 | In distribution |
| 2203-1212 | #1 | In distribution |
| 2203-1237 | #3 | In distribution |
| 2203-1246 | #4 | In distribution |
| 2203-1266 | #6 | In distribution |
| 2203-1220 | #2 | In distribution |
| 2203-1204 | #0 | In distribution |
| 2203-1271 | #7 | In distribution |
| 2203-1238 | #3 | In distribution |
| 2203-1270 | #7 | In distribution |
| 2203-1232 | #3 | In distribution |
| 2203-1277 | #7 | In distribution |
| 2203-1219 | #1 | In distribution |
| 2203-1265 | #6 | In distribution |
| 2203-1249 | #4 | In distribution |
| 2203-1251 | #5 | In distribution |
| 2203-1223 | #2 | In distribution |
| 2203-1268 | #6 | In distribution |
| 2203-1259 | #5 | In distribution |
| 2203-1245 | #4 | In distribution |
| 2203-1235 | #3 | In distribution |
| 2203-1242 | #4 | In distribution |
| 2203-1269 | #6 | In distribution |
| 2203-1210 | #1 | In distribution |
| 2203-1257 | #5 | In distribution |
| 2203-1221 | #2 | In distribution |
| 2203-1253 | #5 | In distribution |
| 2203-1217 | #1 | In distribution |
| 2203-1262 | #6 | In distribution |
| 2203-1244 | #4 | In distribution |
| 2203-1260 | #6 | 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.