NovoKnee Total Knee System
NovoKnee is a cemented total knee replacement system with femoral, tibial and patellar components. A polyethylene tibial insert articulates with the femoral component and snaps into a…
NovoKnee is a cemented total knee replacement system with femoral, tibial and patellar components. A polyethylene tibial insert articulates with the femoral component and snaps into a separate tibial baseplate.
The family includes cruciate-retaining and posterior-stabilized configurations. The posterior-stabilized version uses a tibial post and femoral cam; the cruciate-retaining version omits these features so the posterior cruciate ligament can provide stability.
Listed Item
Tibial EM Alignment Guide Top Shaft Assm Gen 2
Articulating Components
The tibial insert is shaped to conform to the femoral component. The system permits different femoral and tibial sizes to be matched through a common intercondylar geometry. Polyethylene patellar components articulate with the femoral surface, completing the patellofemoral part of the replacement.
21manufacturers in China registered for this device type
427catalogue numbers in this listing
3510(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 | Novosource, LLC, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K131398 |
| Record published | 2018-02-27 |
| Record revised | 2025-07-22 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 9 to 18 mm; outer diameter 11 to 38 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3101-1105 | 5 | In distribution |
| 3311-1044 | Height 15 mm | In distribution |
| 3301-2034 | Height 13 mm | In distribution |
| 3311-3053 | Height 18 mm | In distribution |
| 3311-1045 | Height 15 mm | In distribution |
| 3120-5036 | 6 | In distribution |
| 3201-0002 | 2 | In distribution |
| 3311-3044 | Height 15 mm | In distribution |
| 3211-0011 | 1 | In distribution |
| 3220-5125 | In distribution | |
| 3301-3024 | Height 11 mm | In distribution |
| 3301-2053 | Height 18 mm | In distribution |
| 3320-5000 | In distribution | |
| 3120-5100 | In distribution | |
| 3301-1013 | Height 9 mm | In distribution |
| 3311-1013 | Height 9 mm | In distribution |
| 3120-5023 | In distribution | |
| 3301-4056 | Height 18 mm | In distribution |
| 3211-0003-A | 3 | In distribution |
| 3111-2203 | 3 | In distribution |
| 3111-2202 | 2 | In distribution |
| 3120-5022 | 6 | In distribution |
| 3120-5067 | In distribution | |
| 3101-1103 | 3 | In distribution |
| 3211-0005 | 5 | In distribution |
| 3311-3036 | Height 13 mm | In distribution |
| 3220-5001 | In distribution | |
| 3301-2025 | Height 11 mm | In distribution |
| 3311-2043 | Height 15 mm | In distribution |
| 3301-4022 | Height 11 mm | In distribution |
| 3301-3034 | Height 13 mm | In distribution |
| 3101-2104 | 4 | In distribution |
| 3301-3044 | Height 15 mm | In distribution |
| 3311-3014 | Height 9 mm | In distribution |
| 3220-5033 | In distribution | |
| 3101-2203 | 3 | In distribution |
| 3220-5011 | In distribution | |
| 3311-2023 | Height 11 mm | In distribution |
| 3111-1204 | 4 | In distribution |
| 3301-4051 | Height 18 mm | In distribution |
| 3111-2104 | 4 | In distribution |
| 3211-0013 | 3 | In distribution |
| 3311-4032 | Height 13 mm | In distribution |
| 3120-5002 | In distribution | |
| 3301-1044 | Height 15 mm | In distribution |
| 3311-2052 | Height 18 mm | In distribution |
| 3311-2035 | Height 13 mm | In distribution |
| 3311-2016 | Height 9 mm | In distribution |
| 3301-4014 | Height 9 mm | In distribution |
| 3101-1205 | 5 | In distribution |
| 3111-1101 | 1 | In distribution |
| 3220-5030 | In distribution | |
| 3111-1105 | 5 | In distribution |
| 3301-2012 | Height 9 mm | In distribution |
| 3301-1034 | Height 13 mm | In distribution |
| 3220-5015 | In distribution | |
| 3311-3045 | Height 15 mm | In distribution |
| 3211-0015 | 5 | In distribution |
| 3301-1033 | Height 13 mm | In distribution |
| 3301-4032 | Height 13 mm | In distribution |
| 3301-2033 | Height 13 mm | In distribution |
| 3311-3022 | Height 11 mm | In distribution |
| 3120-5004 | In distribution | |
| 3115-1204 | 4R | In distribution |
| 3301-4044 | Height 15 mm | In distribution |
| 3220-5014 | In distribution | |
| 3301-2021 | Height 11 mm | In distribution |
| 3420-5006 | Outer Diameter 35 mm | In distribution |
| 3301-2045 | Height 15 mm | In distribution |
| 3120-5027 | In distribution | |
| 3220-5032 | In distribution | |
| 3211-0012 | 2 | In distribution |
| 3311-3041 | Height 15 mm | In distribution |
| 3311-2044 | Height 15 mm | In distribution |
| 3301-1043 | Height 15 mm | In distribution |
| 3101-1102 | 2 | In distribution |
| 3311-4015 | Height 9 mm | In distribution |
| 3311-3015 | Height 9 mm | In distribution |
| 3301-1011 | Height 9 mm | In distribution |
| 3211-0005-A | 5 | In distribution |
| 3311-4031 | Height 13 mm | In distribution |
| 3301-1032 | Height 13 mm | In distribution |
| 3301-4031 | Height 13 mm | In distribution |
| 3120-5008 | In distribution | |
| 3301-4024 | Height 11 mm | In distribution |
| 3301-4053 | Height 18 mm | In distribution |
| 3311-3031 | Height 13 mm | In distribution |
| 3211-0006-A | 6 | In distribution |
| 3311-2055 | Height 18 mm | In distribution |
| 3220-5025 | In distribution | |
| 3101-1104 | 4 | In distribution |
| 3120-5038 | In distribution | |
| 3301-1036 | Height 13 mm | In distribution |
| 3301-2026 | Height 11 mm | In distribution |
| 3240-0000 | In distribution | |
| 3301-3012 | Height 9 mm | In distribution |
| 3311-3016 | Height 9 mm | In distribution |
| 3420-5009 | In distribution | |
| 3311-4042 | Height 15 mm | In distribution |
| 3111-2204 | 4 | In distribution |
| 3301-3055 | Height 18 mm | In distribution |
| 3311-1036 | Height 13 mm | In distribution |
| 3311-1034 | Height 13 mm | In distribution |
| 3115-1202 | 2R | In distribution |
| 3311-4034 | Height 13 mm | In distribution |
| 3301-1046 | Height 15 mm | In distribution |
| 3311-2013 | Height 9 mm | In distribution |
| 3311-1046 | Height 15 mm | In distribution |
| 3311-2025 | Height 11 mm | In distribution |
| 3301-4043 | Height 15 mm | In distribution |
| 3301-3042 | Height 15 mm | In distribution |
| 3120-5030 | In distribution | |
| 3301-3015 | Height 9 mm | In distribution |
| 3301-2011 | Height 9 mm | In distribution |
| 3301-4035 | Height 13 mm | In distribution |
| 3311-4056 | Height 18 mm | In distribution |
| 3220-5102 | In distribution | |
| 3311-2024 | Height 11 mm | In distribution |
| 3311-2041 | Height 15 mm | In distribution |
| 3301-4042 | Height 15 mm | In distribution |
| 3401-0080 | Outer Diameter 35 mm | In distribution |
| 3211-0001 | 1 | In distribution |
| 3301-3054 | Height 18 mm | In distribution |
| 3311-3055 | Height 18 mm | In distribution |
| 3301-3023 | Height 11 mm | In distribution |
| 3101-2205 | 5 | In distribution |
| 3301-3032 | Height 13 mm | In distribution |
| 3301-1014 | Height 9 mm | In distribution |
| 3211-0014 | 4 | In distribution |
| 3311-1033 | Height 13 mm | In distribution |
| 3220-5013 | In distribution | |
| 3311-2015 | Height 9 mm | In distribution |
| 3301-4013 | Height 9 mm | In distribution |
| 3120-5001 | In distribution | |
| 3311-2031 | Height 13 mm | In distribution |
| 3311-2034 | Height 13 mm | In distribution |
| 3301-4055 | Height 18 mm | In distribution |
| 3301-2035 | Height 13 mm | In distribution |
| 3120-5021 | 5 | In distribution |
| 3111-1104 | 4 | In distribution |
| 3411-0080 | Outer Diameter 35 mm | In distribution |
| 3101-1201 | 1 | In distribution |
| 3301-1042 | Height 15 mm | In distribution |
| 3220-5022 | In distribution | |
| 3540-0000 | In distribution | |
| 3301-1035 | Height 13 mm | In distribution |
| 3111-2201 | 1 | In distribution |
| 3301-2032 | Height 13 mm | In distribution |
| 3111-1201 | 1 | In distribution |
| 3311-4014 | Height 9 mm | In distribution |
| 3101-2206 | 6 | In distribution |
| 3301-3045 | Height 15 mm | In distribution |
| 3211-0006 | 6 | In distribution |
| 3301-2014 | Height 9 mm | In distribution |
| 3120-5007 | In distribution | |
| 3111-2102 | 2 | In distribution |
| 3301-2052 | Height 18 mm | In distribution |
| 3120-5031 | 1 | In distribution |
| 3311-2045 | Height 15 mm | In distribution |
| 3120-5016 | In distribution | |
| 3301-3014 | Height 9 mm | In distribution |
| 3120-5017 | 1 | In distribution |
| 3311-1043 | Height 15 mm | In distribution |
| 3120-5035 | 5 | In distribution |
| 3301-4036 | Height 13 mm | In distribution |
| 3220-5006 | In distribution | |
| 3311-3032 | Height 13 mm | In distribution |
| 3220-5000 | In distribution | |
| 3301-2036 | Height 13 mm | In distribution |
| 3120-5009 | In distribution | |
| 3311-1052 | Height 18 mm | In distribution |
| 3115-1102 | 2L | In distribution |
| 3311-1032 | Height 13 mm | In distribution |
| 3340-0000 | In distribution | |
| 3311-1042 | Height 15 mm | In distribution |
| 3220-5023 | In distribution | |
| 3311-3054 | Height 18 mm | In distribution |
| 3115-1103 | 3L | In distribution |
| 3201-0001 | 1 | In distribution |
| 3301-4046 | Height 15 mm | In distribution |
| 3311-2032 | Height 13 mm | In distribution |
| 3111-2106 | 6 | In distribution |
| 3111-1103 | 3 | In distribution |
| 3101-1101 | 1 | In distribution |
| 3311-4016 | Height 9 mm | In distribution |
| 3115-1101 | 1L | In distribution |
| 3311-3012 | Height 9 mm | In distribution |
| 3301-1055 | Height 18 mm | In distribution |
| 3301-4054 | Height 18 mm | In distribution |
| 3311-3024 | Height 11 mm | In distribution |
| 3220-5009 | Outer Diameter 15 mm | In distribution |
| 3301-1022 | Height 11 mm | In distribution |
| 3311-2053 | Height 18 mm | In distribution |
| 3120-5018 | 2 | In distribution |
| 3301-3041 | Height 15 mm | In distribution |
| 3301-3033 | Height 13 mm | In distribution |
| 3311-4023 | Height 11 mm | In distribution |
| 3120-5012 | 3 | In distribution |
| 3120-5011 | 2 | In distribution |
| 3301-3022 | Height 11 mm | In distribution |
| 3311-1041 | Height 15 mm | In distribution |
| 3311-4026 | Height 11 mm | In distribution |
| 3101-2204 | 4 | In distribution |
| 3301-3043 | Height 15 mm | In distribution |
| 3311-3043 | Height 15 mm | In distribution |
| 3211-0003 | 3 | In distribution |
| 3111-1106 | 6 | In distribution |
| 3311-1014 | Height 9 mm | In distribution |
| 3301-4025 | Height 11 mm | In distribution |
| 3311-1016 | Height 9 mm | In distribution |
| 3301-3035 | Height 13 mm | In distribution |
| 3120-5010 | 1 | In distribution |
| 3401-0090 | Outer Diameter 38 mm | In distribution |
| 3301-2031 | Height 13 mm | In distribution |
| 3301-1021 | Height 11 mm | In distribution |
| 3311-2046 | Height 15 mm | In distribution |
| 3301-1045 | Height 15 mm | In distribution |
| 3101-2102 | 2 | In distribution |
| 3211-0001-A | 1 | In distribution |
| 3115-1106 | 6R | In distribution |
| 3220-5003 | In distribution | |
| 3211-0004-A | 4 | In distribution |
| 3420-5003 | In distribution | |
| 3301-4015 | Height 9 mm | In distribution |
| 3120-5074 | In distribution | |
| 3301-3051 | Height 18 mm | In distribution |
| 3301-3036 | Height 13 mm | In distribution |
| 3220-5120 | In distribution | |
| 3101-2106 | 6 | In distribution |
| 3311-2012 | Height 9 mm | In distribution |
| 3311-1024 | Height 11 mm | In distribution |
| 3115-1105 | 5L | In distribution |
| 3311-4021 | Height 11 mm | In distribution |
| 3301-1025 | Height 11 mm | In distribution |
| 3111-1203 | 3 | In distribution |
| 3220-5016 | In distribution | |
| 3111-1205 | 5 | In distribution |
| 3401-0060 | Outer Diameter 29 mm | In distribution |
| 3115-1205 | 5R | In distribution |
| 3120-5033 | 3 | In distribution |
| 3311-2051 | Height 18 mm | In distribution |
| 3311-4024 | Height 11 mm | In distribution |
| 3311-3051 | Height 18 mm | In distribution |
| 3111-1206 | 6 | In distribution |
| 3311-2011 | Height 9 mm | In distribution |
| 3301-1056 | Height 18 mm | In distribution |
| 3120-5024 | In distribution | |
| 3301-4041 | Height 15 mm | In distribution |
| 3301-1016 | Height 9 mm | In distribution |
| 3211-0004 | 4 | 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 |
|---|---|
| K261032 | 2026-04-27 |
| K131398 | 2013-09-16 |
| K123339 | 2013-04-11 |
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.