Freedom Partial Knee

PARTIAL FEMORAL w/ PARTIAL POST, MEDIUM, RIGHT MEDIAL

Registry build 21.09.26
21manufacturers in China registered for this device type
27catalogue 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.

Chinese manufacturers registered for FDA product code JWH
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

Regulatory record for Freedom Partial Knee
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) K072704
Record published 2015-10-20
Record revised 2018-07-06 (version 3)

Specifications

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 Height 6.5 to 8.5 mm
Distribution end date 2016-02-17

Catalogue Numbers

Catalogue numbers for Freedom Partial Knee
Catalogue number Size Status
311367 Height 7.5 mm In distribution
313451 In distribution
314450 In distribution
313500 In distribution
311327 Height 7.5 mm In distribution
314500 In distribution
311368 Height 8.5 mm In distribution
314451 In distribution
311328 Height 8.5 mm In distribution
314541 In distribution
313541 In distribution
314540 In distribution
311366 Height 6.5 mm In distribution
311408 Height 8.5 mm In distribution
311406 Height 6.5 mm In distribution
311407 Height 7.5 mm In distribution
313540 In distribution
313450 In distribution
313501 In distribution
311326 Height 6.5 mm In distribution
314501 In distribution
312326 Height 6.5 mm Withdrawn
312366 Height 6.5 mm Withdrawn
312407 Height 7.5 mm Withdrawn
312406 Height 6.5 mm Withdrawn
312327 Height 7.5 mm Withdrawn
312367 Height 7.5 mm Withdrawn

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer