Lospa Total Knee System
LOSPA Total Knee System is a cemented knee replacement family with femoral components, tibial baseplates, polyethylene inserts and patellar components. The metal femoral component…
LOSPA Total Knee System is a cemented knee replacement family with femoral components, tibial baseplates, polyethylene inserts and patellar components. The metal femoral component articulates against the insert supported by the tibial baseplate.
Femoral designs include cruciate-retaining and posterior-stabilized versions for the right or left knee. The femoral components and tibial baseplates are cobalt-chromium-molybdenum alloy, while the inserts are UHMWPE.
Listed Item
LOSPA Femoral Component (PS)(Right)
Component Matching
Tibial baseplates accommodate the corresponding CR or PS inserts and femoral designs. Different component sizes and insert thicknesses provide matching options within the system; a right PS femoral component is one part of that assembly.
21manufacturers in China registered for this device type
368catalogue numbers in this listing
12510(k) clearances naming this product code
2recalls 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 | Corentec Co., Ltd., South Korea |
|---|---|
| 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 | Manufacturer, Exporter |
| 510(k) | K130673 |
| Record published | 2015-10-07 |
| Record revised | 2021-02-05 (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
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| 01.10.9AA | In distribution | |
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Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K250889 | 2025-04-17 |
| K242401 | 2024-09-12 |
| K242046 | 2024-08-01 |
| K222278 | 2022-08-26 |
| K212034 | 2021-12-09 |
| K201851 | 2020-07-30 |
| K200395 | 2020-05-07 |
| K192507 | 2019-12-11 |
| K160157 | 2016-12-01 |
| K130673 | 2013-04-15 |
| K121037 | 2012-05-03 |
| K110404 | 2012-02-16 |
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 |
|---|---|---|---|---|---|---|
| Corentec Co., Ltd. | 510(k) number | 2024-03-29 | Class II | Labeling Change Control | Due to unsupported 10 year expiration date. | 397 |
| Corentec Co., Ltd. | 510(k) number | 2024-03-29 | Class II | Labeling Change Control | Due to unsupported 10 year expiration date. | 35 |
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.