DJO Surgical
3D KNEE CEMENTED FEMORAL COMPONENT, TiNbN COATED, SZ 10, LEFT
21manufacturers in China registered for this device type
40catalogue numbers in this listing
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 | DJO, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K122239 |
| Record published | 2016-07-13 |
| Record revised | 2018-07-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 201-08-104 | In distribution | |
| 202-09-105 | In distribution | |
| 202-09-102 | In distribution | |
| 202-09-112 | In distribution | |
| 201-08-107 | In distribution | |
| 233-08-102 | In distribution | |
| 233-08-106 | In distribution | |
| 323-01-103 | In distribution | |
| 202-09-104 | In distribution | |
| 233-08-107 | In distribution | |
| 233-09-112 | In distribution | |
| 233-09-104 | In distribution | |
| 233-08-110 | In distribution | |
| 322-10-101 | In distribution | |
| 233-08-108 | In distribution | |
| 201-08-112 | In distribution | |
| 220-15-110 | In distribution | |
| 233-09-105 | In distribution | |
| 202-09-108 | In distribution | |
| 201-08-106 | In distribution | |
| 233-09-106 | In distribution | |
| 233-09-103 | In distribution | |
| 233-08-103 | In distribution | |
| 201-08-102 | In distribution | |
| 202-09-107 | In distribution | |
| 233-08-105 | In distribution | |
| 202-09-103 | In distribution | |
| 201-08-103 | In distribution | |
| 201-08-110 | In distribution | |
| 324-01-103 | In distribution | |
| 233-08-112 | In distribution | |
| 233-09-102 | In distribution | |
| 201-08-108 | In distribution | |
| 233-08-104 | In distribution | |
| 233-09-110 | In distribution | |
| 233-09-108 | In distribution | |
| 202-09-110 | In distribution | |
| 201-08-105 | In distribution | |
| 233-09-107 | In distribution | |
| 202-09-106 | In distribution |
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
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2008-08-04 | Not classified | Device Design | Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery. | 68 units. | 2009-08-03 |
| Encore Medical, L.P. | 510(k) number | 2005-11-03 | Not classified | Other | The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function. | 16 units. | 2008-04-04 |
| Encore Medical, L.P. | 510(k) number | 2004-05-10 | Not classified | Other | Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE | 15 | 2004-08-09 |
| Encore Medical, L.P. | 510(k) number | 2003-04-24 | Not classified | Other | Product container was labeled incorrectly indicating left femur instead of right. | 14 unimplanted units | 2003-07-29 |
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.