Tibial Insert, PSA Type
Tibial insert, PSA type, #4, 30mm
21manufacturers in China registered for this device type
48catalogue numbers in this listing
20510(k) clearances naming this product code
3recalls on this code
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) | K082424 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-18 (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 |
|---|---|---|
| 2303-5048 | 30mm | In distribution |
| 2303-5041 | 9mm | In distribution |
| 2303-5035 | 18mm | In distribution |
| 2303-5024 | 15mm | In distribution |
| 2303-5068 | 30mm | In distribution |
| 2303-5014 | 15mm | In distribution |
| 2303-5023 | 13mm | In distribution |
| 2303-5013 | 13mm | In distribution |
| 2303-5043 | 13mm | In distribution |
| 2303-5051 | 9mm | In distribution |
| 2303-5066 | 21mm | In distribution |
| 2303-5015 | 18mm | In distribution |
| 2303-5063 | 13mm | In distribution |
| 2303-5067 | 25mm | In distribution |
| 2303-5044 | 15mm | In distribution |
| 2303-5022 | 11mm | In distribution |
| 2303-5033 | 13mm | In distribution |
| 2303-5045 | 18mm | In distribution |
| 2303-5031 | 9mm | In distribution |
| 2303-5065 | 18mm | In distribution |
| 2303-5061 | 9mm | In distribution |
| 2303-5016 | 21mm | In distribution |
| 2303-5036 | 21mm | In distribution |
| 2303-5011 | 9mm | In distribution |
| 2303-5034 | 15mm | In distribution |
| 2303-5054 | 15mm | In distribution |
| 2303-5057 | 25mm | In distribution |
| 2303-5053 | 13mm | In distribution |
| 2303-5058 | 30mm | In distribution |
| 2303-5018 | 30mm | In distribution |
| 2303-5047 | 25mm | In distribution |
| 2303-5028 | 30mm | In distribution |
| 2303-5042 | 11mm | In distribution |
| 2303-5038 | 30mm | In distribution |
| 2303-5064 | 15mm | In distribution |
| 2303-5026 | 21mm | In distribution |
| 2303-5032 | 11mm | In distribution |
| 2303-5021 | 9mm | In distribution |
| 2303-5056 | 21mm | In distribution |
| 2303-5027 | 25mm | In distribution |
| 2303-5037 | 25mm | In distribution |
| 2303-5046 | 21mm | In distribution |
| 2303-5052 | 11mm | In distribution |
| 2303-5055 | 18mm | In distribution |
| 2303-5017 | 25mm | In distribution |
| 2303-5062 | 11mm | In distribution |
| 2303-5012 | 11mm | In distribution |
| 2303-5025 | 18mm | 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 |
|---|---|---|---|---|---|---|---|
| United Orthopedic Corp. | 510(k) number | 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 | |
| United Orthopedic Corp. | 510(k) number | 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 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 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.