Freedom Stemmed
Posterior Femoral Augment Size D
21manufacturers in China registered for this device type
60catalogue numbers in this listing
15510(k) clearances naming this product 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 | Maxx Orthopedics Inc., United States |
|---|---|
| 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 | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K111785 |
| Record published | 2015-10-07 |
| Record revised | 2020-04-20 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 5 to 150 mm; width 6 to 37.1 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RGPSDG00-RK | Length 23.5 mm | In distribution |
| RSUU4105-RK | Width 10.5 mm | In distribution |
| RSUU3135-RK | Width 13.5 mm | In distribution |
| RSUU3120-RK | Length 100 mm | In distribution |
| RSUU4120-RK | Width 12 mm | In distribution |
| RGPSDA00-RK | In distribution | |
| RAUUX500-RK | Length 45.20 mm | In distribution |
| RSUU3180-RK | Width 18 mm | In distribution |
| RRUUX412-RK | Length 10 mm | In distribution |
| RSUU1090-RK | Width 9 mm | In distribution |
| RGPSDB00-RK | Length 18 mm | In distribution |
| RSUU3090-RK | Width 9 mm | In distribution |
| RAUUX400-RK | Width 31.10 mm | In distribution |
| RSUU2165-RK | Width 16.5 mm | In distribution |
| RGPSPD00-RK | In distribution | |
| RAUUX000-RK | Width 26.6 mm | In distribution |
| RAUUX600-RK | Width 34.10 mm | In distribution |
| RSUU2180-RK | Length 75 mm | In distribution |
| RSUU2090-RK | Length 75 mm | In distribution |
| RSUU3165-RK | Length 100 mm | In distribution |
| RSUU2150-RK | Length 75 mm | In distribution |
| RSUU4090-RK | Length 150 mm | In distribution |
| RSUU2200-RK | Width 20 mm | In distribution |
| RSUU3105-RK | Length 100 mm | In distribution |
| RRUUX407-RK | Length 5 mm | In distribution |
| RJPSX600-RK | Width 6 mm | In distribution |
| RSUU3075-RK | Width 7.5 mm | In distribution |
| RGPSDF00-RK | Width 18 mm | In distribution |
| RSUU4135-RK | Length 150 mm | In distribution |
| RGPSPC00-RK | Width 6.56 mm | In distribution |
| RGPSDE00-RK | Length 21.5 mm | In distribution |
| RAUUX700-RK | Length 49.20 mm | In distribution |
| RSUU2120-RK | Width 12 mm | In distribution |
| RSUU1150-RK | Width 15 mm | In distribution |
| RSUU4150-RK | Length 150 mm | In distribution |
| RGPSDD00-RK | In distribution | |
| RSUU4165-RK | Width 16.5 mm | In distribution |
| RGPSPA00-RK | In distribution | |
| RGPSPH00-RK | Width 10 mm | In distribution |
| RGPSPB00-RK | Length 14.5 mm | In distribution |
| RGPSPG00-RK | Length 19 mm | In distribution |
| RSUU2135-RK | Length 75 mm | In distribution |
| RSUU4075-RK | Length 150 mm | In distribution |
| RJPSX400-RK | Width 8 mm | In distribution |
| RAUUX300-RK | Length 39.20 mm | In distribution |
| RSUU3200-RK | Length 100 mm | In distribution |
| RGPSDC00-RK | Width 15 mm | In distribution |
| RSUU4200-RK | Width 20 mm | In distribution |
| RSUU2105-RK | Width 10.5 mm | In distribution |
| RRUUX417-RK | Length 15 mm | In distribution |
| RSUU2075-RK | Length 75 mm | In distribution |
| RSUU4180-RK | Length 150 mm | In distribution |
| RSUU3150-RK | Width 15 mm | In distribution |
| RAUUX800-RK | Width 37.10 mm | In distribution |
| RGPSPF00-RK | Width 8.78 mm | In distribution |
| RGPSPE00-RK | Length 17 mm | In distribution |
| RSUU1120-RK | Length 40 mm | In distribution |
| RAUUX100-RK | Length 37.64 mm | In distribution |
| RGPSDH00-RK | Width 20.5 mm | In distribution |
| RAUUX200-RK | Width 28.92 mm | 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 |
|---|---|
| K261563 | 2026-08-07 |
| K253314 | 2025-10-29 |
| K253144 | 2025-10-22 |
| K251717 | 2025-06-26 |
| K250382 | 2025-03-13 |
| K243277 | 2024-11-19 |
| K240863 | 2024-07-02 |
| K200912 | 2020-11-18 |
| K192148 | 2019-09-05 |
| K182574 | 2019-01-22 |
| K131481 | 2014-02-21 |
| K111785 | 2012-06-29 |
| K091280 | 2009-09-25 |
| K090411 | 2009-04-07 |
| K082019 | 2009-02-06 |
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.