Freedom
Unicondylar Tibial Liner Size 2, 10mm, Left Medial/Right Lateral
6manufacturers in China registered for this device type
72catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Maxx Orthopedics Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212870 |
| Record published | 2025-07-03 |
| Record revised | 2025-07-11 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DULMRL609-UK | In distribution | |
| DULMRL210-UK | In distribution | |
| ACRMLL200-UK | In distribution | |
| DURMLL611-UK | In distribution | |
| DURMLL509-UK | In distribution | |
| DURMLL408-UK | In distribution | |
| DURMLL211-UK | In distribution | |
| DURMLL508-UK | In distribution | |
| DULMRL111-UK | In distribution | |
| DURMLL308-UK | In distribution | |
| BTRMLL500-UK | In distribution | |
| ACLMRL300-UK | In distribution | |
| DURMLL610-UK | In distribution | |
| DULMRL109-UK | In distribution | |
| ACLMRL600-UK | In distribution | |
| DULMRL108-UK | In distribution | |
| DURMLL511-UK | In distribution | |
| DURMLL309-UK | In distribution | |
| BTLMRL100-UK | In distribution | |
| ACLMRL200-UK | In distribution | |
| DULMRL508-UK | In distribution | |
| DULMRL410-UK | In distribution | |
| ACLMRL500-UK | In distribution | |
| DURMLL311-UK | In distribution | |
| DULMRL408-UK | In distribution | |
| BTRMLL100-UK | In distribution | |
| DULMRL510-UK | In distribution | |
| ACLMRL100-UK | In distribution | |
| DURMLL108-UK | In distribution | |
| DURMLL209-UK | In distribution | |
| DURMLL608-UK | In distribution | |
| ACRMLL600-UK | In distribution | |
| DULMRL208-UK | In distribution | |
| ACRMLL100-UK | In distribution | |
| DULMRL311-UK | In distribution | |
| DURMLL409-UK | In distribution | |
| DULMRL310-UK | In distribution | |
| DURMLL310-UK | In distribution | |
| BTRMLL400-UK | In distribution | |
| DULMRL308-UK | In distribution | |
| ACRMLL300-UK | In distribution | |
| BTLMRL300-UK | In distribution | |
| BTRMLL300-UK | In distribution | |
| DULMRL211-UK | In distribution | |
| DURMLL210-UK | In distribution | |
| ACRMLL400-UK | In distribution | |
| ACRMLL500-UK | In distribution | |
| DULMRL209-UK | In distribution | |
| BTLMRL400-UK | In distribution | |
| DULMRL611-UK | In distribution | |
| DULMRL511-UK | In distribution | |
| DURMLL609-UK | In distribution | |
| BTLMRL200-UK | In distribution | |
| DURMLL110-UK | In distribution | |
| DULMRL309-UK | In distribution | |
| ACLMRL400-UK | In distribution | |
| DULMRL610-UK | In distribution | |
| DULMRL509-UK | In distribution | |
| DURMLL111-UK | In distribution | |
| DULMRL608-UK | In distribution | |
| BTLMRL500-UK | In distribution | |
| DURMLL411-UK | In distribution | |
| BTRMLL200-UK | In distribution | |
| DURMLL510-UK | In distribution | |
| DURMLL410-UK | In distribution | |
| BTRMLL600-UK | In distribution | |
| DURMLL109-UK | In distribution | |
| DULMRL411-UK | In distribution | |
| DULMRL110-UK | In distribution | |
| DULMRL409-UK | In distribution | |
| BTLMRL600-UK | In distribution | |
| DURMLL208-UK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261609 | 2026-08-04 |
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.