Freedom Knee
Freedom Tibial Liner Size D1-2, Primary PCK
21manufacturers in China registered for this device type
336catalogue 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) | K090411 |
| Record published | 2025-07-24 |
| Record revised | 2019-12-11 (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, manufacturing date |
| Sizes | Depth 8 to 20 mm; width 25 to 80 mm; length 40 to 74 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MLUCXG713-K | In distribution | |
| MLPSXD109-K | Depth 9 mm | In distribution |
| ALCRXG717-K | Depth 17 mm | In distribution |
| MLCRXB111-K | Depth 11 mm | In distribution |
| ALPSXA109-K | Depth 9 mm | In distribution |
| MLCRXF514-K | Depth 14 mm | In distribution |
| ALPSXD411-K | Depth 11 mm | In distribution |
| MLUCXD113-K | In distribution | |
| MLUCXB119-K | In distribution | |
| UFCRLA00-K | Width 56 mm | In distribution |
| MLCRXG714-K | Depth 14 mm | In distribution |
| MLPSXG709-K | Depth 9 mm | In distribution |
| ALCRXB211-K | Depth 11 mm | In distribution |
| MTUUX800-K | Width 78 mm | In distribution |
| MLUCXH716-K | In distribution | |
| MLUCXA119-K | In distribution | |
| ALPSXH709-K | Depth 9 mm | In distribution |
| MLUCXA113-K | In distribution | |
| MLCRXE511-K | Depth 11 mm | In distribution |
| MLPSXC114-K | Depth 14 mm | In distribution |
| MLCRXE311-K | Depth 11 mm | In distribution |
| MLUCXE513-K | In distribution | |
| MLCRXG509-K | Depth 9 mm | In distribution |
| MLCRXD314-K | Depth 14 mm | In distribution |
| ALPSXC211-K | Depth 11 mm | In distribution |
| ALPSXC314-K | Depth 14 mm | In distribution |
| ALPSXF511-K | Depth 11 mm | In distribution |
| ALPSXC209-K | Depth 9 mm | In distribution |
| ALCRXE520-K | Depth 20 mm | In distribution |
| ALPSXC214-K | Depth 14 mm | In distribution |
| ALCRXE417-K | Depth 17 mm | In distribution |
| ALPSXH720-K | Depth 20 mm | In distribution |
| ALPSXG717-K | Depth 17 mm | In distribution |
| MLPSXF717-K | Depth 17 mm | In distribution |
| ALPSXA117-K | Depth 17 mm | In distribution |
| UFCRRF00-K | Length 66 mm | In distribution |
| ALPSXE517-K | Depth 17 mm | In distribution |
| MLCRXC317-K | Depth 17 mm | In distribution |
| ALCRXD214-K | Depth 14 mm | In distribution |
| MLPSXB117-K | Depth 17 mm | In distribution |
| ALCRXB214-K | Depth 14 mm | In distribution |
| MLCRXF517-K | Depth 17 mm | In distribution |
| MLPSXC314-K | Depth 14 mm | In distribution |
| ALPSXF509-K | Depth 9 mm | In distribution |
| MLUCXF519-K | In distribution | |
| MLUCXH713-K | In distribution | |
| ALCRXH717-K | Depth 17 mm | In distribution |
| ALCRXD320-K | Depth 20 mm | In distribution |
| MLPSXF309-K | Depth 9 mm | In distribution |
| MLUCXD316-K | In distribution | |
| ALPSXD209-K | Depth 9 mm | In distribution |
| UFCRLH00-K | Width 80 mm | In distribution |
| UPUUX834-K | Width 34 mm | In distribution |
| ALPSXG720-K | Depth 20 mm | In distribution |
| MLUCXF316-K | In distribution | |
| UFCRRD00-K | Length 60 mm | In distribution |
| LLPSXD110-ML | In distribution | |
| ALPSXD309-K | Depth 9 mm | In distribution |
| UFPSLH00-K | Length 74 mm | In distribution |
| ALPSXD420-K | Depth 20 mm | In distribution |
| MLPSXG517-K | Depth 17 mm | In distribution |
| MLUCXD119-K | In distribution | |
| ALCRXE517-K | Depth 17 mm | In distribution |
| MLPSXD117-K | Depth 17 mm | In distribution |
| UFPSRD00-K | Length 60 mm | In distribution |
| ALCRXE411-K | Depth 11 mm | In distribution |
| MLCRXG514-K | Depth 14 mm | In distribution |
| MLPSXG714-K | Depth 14 mm | In distribution |
| MLUCXE319-K | In distribution | |
| MLCRXC314-K | Depth 14 mm | In distribution |
| ALCRXG720-K | Depth 20 mm | In distribution |
| ALPSXE420-K | Depth 20 mm | In distribution |
| ALCRXH711-K | Depth 11 mm | In distribution |
| UFPSLG00-K | Length 70 mm | In distribution |
| MLCRXF309-K | Depth 9 mm | In distribution |
| MLUCXC113-K | In distribution | |
| MLPSXC117-K | Depth 17 mm | In distribution |
| MLUCXE519-K | In distribution | |
| MLCRXH714-K | Depth 14 mm | In distribution |
| MLUCXE516-K | In distribution | |
| ALCRXE509-K | Depth 9 mm | In distribution |
| ALCRXG709-K | Depth 9 mm | In distribution |
| UFPSRH00-K | Length 74 mm | In distribution |
| ALCRXC209-K | Depth 9 mm | In distribution |
| MLPSXH714-K | Depth 14 mm | In distribution |
| MLCRXF717-K | Depth 17 mm | In distribution |
| ALPSXE414-K | Depth 14 mm | In distribution |
| MLCRXG511-K | Depth 11 mm | In distribution |
| LLPSXD312-ML | In distribution | |
| UFPSRE00-K | Length 62 mm | In distribution |
| MLCRXA111-K | Depth 11 mm | In distribution |
| MLPSXD311-K | Depth 11 mm | In distribution |
| MTUUX700-K | Length 52 mm | In distribution |
| UFPSLF00-K | Length 66 mm | In distribution |
| UFPSRB00-K | Length 54 mm | In distribution |
| UFPSRG00-K | Length 70 mm | In distribution |
| MLPSXE317-K | Depth 17 mm | In distribution |
| MLCRXD117-K | Depth 17 mm | In distribution |
| MLPSXF714-K | Depth 14 mm | In distribution |
| MLCRXD311-K | Depth 11 mm | In distribution |
| UFCRRH00-K | Length 74 mm | In distribution |
| MLUCXF713-K | In distribution | |
| ALCRXC220-K | Depth 20 mm | In distribution |
| MLPSXG514-K | Depth 14 mm | In distribution |
| ALPSXF517-K | Depth 17 mm | In distribution |
| MLUCXA115-K | In distribution | |
| MLUCXD319-K | In distribution | |
| LLPSXD112-ML | In distribution | |
| ALCRXF514-K | Depth 14 mm | In distribution |
| ALCRXD420-K | Depth 20 mm | In distribution |
| MLPSXB114-K | Depth 14 mm | In distribution |
| ALCRXC320-K | Depth 20 mm | In distribution |
| ALPSXD311-K | Depth 11 mm | In distribution |
| ALCRXD309-K | Depth 9 mm | In distribution |
| ALPSXE411-K | Depth 11 mm | In distribution |
| MLUCXF516-K | In distribution | |
| MLUCXG516-K | In distribution | |
| UPUUX828-K | Width 28 mm | In distribution |
| MLPSXA109-K | Depth 9 mm | In distribution |
| UPUUX825-K | Depth 8 mm | In distribution |
| MLUCXA110-K | In distribution | |
| MLCRXF709-K | Depth 9 mm | In distribution |
| MLCRXC311-K | Depth 11 mm | In distribution |
| UPUUX831-K | Depth 8 mm | In distribution |
| ALPSXH717-K | Depth 17 mm | In distribution |
| UFCRRG00-K | Length 70 mm | In distribution |
| ALPSXG709-K | Depth 9 mm | In distribution |
| MLUCXA114-K | In distribution | |
| MLPSXB109-K | Depth 9 mm | In distribution |
| MLUCXF513-K | In distribution | |
| MLPSXG711-K | Depth 11 mm | In distribution |
| ALPSXD211-K | Depth 11 mm | In distribution |
| MLUCXC319-K | In distribution | |
| ALPSXD217-K | Depth 17 mm | In distribution |
| ALCRXA114-K | Depth 14 mm | In distribution |
| MLPSXA114-K | Depth 14 mm | In distribution |
| ALPSXD320-K | Depth 20 mm | In distribution |
| ALPSXD220-K | Depth 20 mm | In distribution |
| ALCRXD209-K | Depth 9 mm | In distribution |
| MLUCXE313-K | In distribution | |
| ALPSXB211-K | Depth 11 mm | In distribution |
| UFCRRC00-K | Length 58 mm | In distribution |
| ALCRXH720-K | Depth 20 mm | In distribution |
| MLPSXC109-K | Depth 9 mm | In distribution |
| MLCRXG711-K | Depth 11 mm | In distribution |
| ALPSXG711-K | Depth 11 mm | In distribution |
| MLPSXC317-K | Depth 17 mm | In distribution |
| MTUUX100-K | Length 40 mm | In distribution |
| MLPSXG717-K | Depth 17 mm | In distribution |
| MLUCXA112-K | In distribution | |
| ALCRXD217-K | Depth 17 mm | In distribution |
| UFPSRF00-K | Length 66 mm | In distribution |
| MLPSXE309-K | Depth 9 mm | In distribution |
| ALPSXB220-K | Depth 20 mm | In distribution |
| ALPSXD409-K | Depth 9 mm | In distribution |
| ALPSXE520-K | Depth 20 mm | In distribution |
| MLCRXF311-K | Depth 11 mm | In distribution |
| MLPSXC311-K | Depth 11 mm | In distribution |
| ALCRXA111-K | Depth 11 mm | In distribution |
| ALCRXB209-K | Depth 9 mm | In distribution |
| ALPSXB214-K | Depth 14 mm | In distribution |
| ALCRXE420-K | Depth 20 mm | In distribution |
| MLCRXA117-K | Depth 17 mm | In distribution |
| ALPSXC217-K | Depth 17 mm | In distribution |
| UFCRLF00-K | Width 72 mm | In distribution |
| MTUUX200-K | Width 62 mm | In distribution |
| UFCRLC00-K | Width 62 mm | In distribution |
| MLPSXF709-K | Depth 9 mm | In distribution |
| ALCRXC217-K | Depth 17 mm | In distribution |
| MLCRXF314-K | Depth 14 mm | In distribution |
| MLUCXC316-K | In distribution | |
| MLCRXD317-K | Depth 17 mm | In distribution |
| MLCRXC309-K | Depth 9 mm | In distribution |
| MLUCXF719-K | In distribution | |
| MLCRXB114-K | Depth 14 mm | In distribution |
| ALCRXF511-K | Depth 11 mm | In distribution |
| ALPSXC309-K | Depth 9 mm | In distribution |
| ALCRXF509-K | Depth 9 mm | In distribution |
| UFCRRE00-K | Length 62 mm | In distribution |
| MLPSXG511-K | Depth 11 mm | In distribution |
| MLCRXH709-K | Depth 9 mm | In distribution |
| UFPSLC00-K | Length 58 mm | In distribution |
| MLPSXE511-K | Depth 11 mm | In distribution |
| MLPSXD317-K | Depth 17 mm | In distribution |
| ALCRXC211-K | Depth 11 mm | In distribution |
| MLUCXC116-K | In distribution | |
| ALPSXE417-K | Depth 17 mm | In distribution |
| ALCRXD409-K | Depth 9 mm | In distribution |
| MLCRXD114-K | Depth 14 mm | In distribution |
| ALPSXF520-K | Depth 20 mm | In distribution |
| MLPSXC111-K | Depth 11 mm | In distribution |
| MLPSXB111-K | Depth 11 mm | In distribution |
| MLPSXE311-K | Depth 11 mm | In distribution |
| MTUUX500-K | Length 48 mm | In distribution |
| MLUCXD313-K | In distribution | |
| UFCRLG00-K | Width 76 mm | In distribution |
| LLPSXD310-ML | In distribution | |
| ALPSXA120-K | Depth 20 mm | In distribution |
| MLUCXF313-K | In distribution | |
| ALCRXD417-K | Depth 17 mm | In distribution |
| MLCRXE314-K | Depth 14 mm | In distribution |
| MLPSXF314-K | Depth 14 mm | In distribution |
| ALPSXC311-K | Depth 11 mm | In distribution |
| MLCRXF509-K | Depth 9 mm | In distribution |
| ALPSXE509-K | Depth 9 mm | In distribution |
| MLPSXF311-K | Depth 11 mm | In distribution |
| ALCRXD411-K | Depth 11 mm | In distribution |
| MLPSXG509-K | Depth 9 mm | In distribution |
| MLCRXE309-K | Depth 9 mm | In distribution |
| MLCRXD309-K | Depth 9 mm | In distribution |
| ALPSXH711-K | Depth 11 mm | In distribution |
| UFCRRA00-K | Length 51 mm | In distribution |
| ALCRXF520-K | Depth 20 mm | In distribution |
| ALCRXD220-K | Depth 20 mm | In distribution |
| ALCRXG711-K | Depth 11 mm | In distribution |
| MLUCXA116-K | In distribution | |
| ALPSXB209-K | Depth 9 mm | In distribution |
| ALCRXE409-K | Depth 9 mm | In distribution |
| ALPSXB217-K | Depth 17 mm | In distribution |
| MLUCXG513-K | In distribution | |
| ALCRXD414-K | Depth 14 mm | In distribution |
| ALPSXD314-K | Depth 14 mm | In distribution |
| ALCRXH709-K | Depth 9 mm | In distribution |
| MLUCXA117-K | In distribution | |
| ALPSXE409-K | Depth 9 mm | In distribution |
| UFPSRA00-K | Length 51 mm | In distribution |
| MLUCXF716-K | In distribution | |
| MLPSXF317-K | Depth 17 mm | In distribution |
| ALPSXC320-K | Depth 20 mm | In distribution |
| ALCRXG714-K | Depth 14 mm | In distribution |
| ALCRXC314-K | Depth 14 mm | In distribution |
| MLCRXG709-K | Depth 9 mm | In distribution |
| ALCRXC311-K | Depth 11 mm | In distribution |
| UFCRLB00-K | Width 58 mm | In distribution |
| MLUCXF319-K | In distribution | |
| MLUCXH719-K | In distribution | |
| MLCRXH711-K | Depth 11 mm | In distribution |
| ALCRXA109-K | Depth 9 mm | In distribution |
| MLPSXF711-K | Depth 11 mm | In distribution |
| UFPSLB00-K | Length 54 mm | In distribution |
| ALPSXD317-K | Depth 17 mm | In distribution |
| MLUCXE316-K | In distribution | |
| MLUCXG519-K | In distribution | |
| MLPSXA111-K | Depth 11 mm | In distribution |
| MLCRXC114-K | Depth 14 mm | In distribution |
| MLCRXH717-K | Depth 17 mm | In distribution |
| MLCRXC109-K | Depth 9 mm | In distribution |
| ALCRXA117-K | Depth 17 mm | In distribution |
| LLPSXD313-ML | In distribution | |
| MLPSXA117-K | Depth 17 mm | In distribution |
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 |
|---|---|
| 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.