Freedom Knee Cementless
Cementless Femoral Size F, PS, Right
12manufacturers in China registered for this device type
32catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Maxx Orthopedics Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K150680 |
| Record published | 2015-10-13 |
| Record revised | 2018-07-06 (version 3) |
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 51 to 74 mm; depth 56 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFPSLG00-PK | Length 70 mm | In distribution |
| PFPSRF00-PK | Depth 72 mm | In distribution |
| PFPSRB00-PK | Depth 58 mm | In distribution |
| PFCRLB00-PK | Length 54 mm | In distribution |
| PFCRRA00-PK | Length 51 mm | In distribution |
| PFCRLE00-PK | Length 62 mm | In distribution |
| PFPSRC00-PK | Length 58 mm | In distribution |
| PFPSLH00-PK | Depth 80 mm | In distribution |
| PFCRLA00-PK | Depth 56 mm | In distribution |
| PFPSLA00-PK | Length 51 mm | In distribution |
| PFCRRB00-PK | Depth 58 mm | In distribution |
| PFPSLC00-PK | Length 58 mm | In distribution |
| PFCRRG00-PK | Length 70 mm | In distribution |
| PFPSLD00-PK | Depth 65 mm | In distribution |
| PFPSLF00-PK | Depth 72 mm | In distribution |
| PFCRLD00-PK | Depth 65 mm | In distribution |
| PFCRRF00-PK | Depth 72 mm | In distribution |
| PFCRLC00-PK | Depth 62 mm | In distribution |
| PFPSLB00-PK | Depth 58 mm | In distribution |
| PFPSRH00-PK | Depth 80 mm | In distribution |
| PFPSRE00-PK | Length 62 mm | In distribution |
| PFCRRE00-PK | Length 62 mm | In distribution |
| PFCRLH00-PK | Depth 80 mm | In distribution |
| PFCRLG00-PK | Length 70 mm | In distribution |
| PFPSRA00-PK | Length 51 mm | In distribution |
| PFPSLE00-PK | Length 62 mm | In distribution |
| PFCRRD00-PK | Depth 65 mm | In distribution |
| PFCRRC00-PK | Length 58 mm | In distribution |
| PFCRLF00-PK | Depth 72 mm | In distribution |
| PFPSRG00-PK | Length 70 mm | In distribution |
| PFPSRD00-PK | Depth 65 mm | In distribution |
| PFCRRH00-PK | Depth 80 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252777 | 2025-10-31 |
| K241597 | 2025-02-13 |
| K150680 | 2015-06-26 |
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.