Alliant Biotech
Symmetric Total Knee Ultracongruent Tibial Insert Size 6x18
21manufacturers in China registered for this device type
140catalogue 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 | Medisurge, 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 |
| 510(k) | K100370 |
| Record published | 2024-08-02 |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20×100 | In distribution | |
| 26×150 | In distribution | |
| 6×18 Ultracongruent | In distribution | |
| 4×20 Standard | In distribution | |
| 3×20 Standard | In distribution | |
| 5×12 Standard | In distribution | |
| 6×16 Standard | In distribution | |
| 22×100 | In distribution | |
| 22×150 | In distribution | |
| 4×10 Standard | In distribution | |
| 7×12 Standard | In distribution | |
| 20×200 | In distribution | |
| 3×18 Standard | In distribution | |
| 4×20 Ultracongruent | In distribution | |
| 16×150 | In distribution | |
| 7×14 Ultracongruent | In distribution | |
| 7×14 Standard | In distribution | |
| 6LT | In distribution | |
| 3×25 Ultracongruent | In distribution | |
| 6×20 Ultracongruent | In distribution | |
| 32/50 | In distribution | |
| 6×25 Ultracongruent | In distribution | |
| Distal Full 3-4 | In distribution | |
| 16×100 | In distribution | |
| 6×10 Ultracongruent | In distribution | |
| 5×35 Ultracongruent | In distribution | |
| Distal Full 7-8 | In distribution | |
| 5×20 Ultracongruent | In distribution | |
| 5×18 Standard | In distribution | |
| 22×200 | In distribution | |
| 4×10 Ultracongruent | In distribution | |
| 4×18 Ultracongruent | In distribution | |
| Posterior Thick 3-4 | In distribution | |
| 6×20 Standard | In distribution | |
| 6×12 Ultracongruent | In distribution | |
| Distal Full 5-6 | In distribution | |
| 3×14 Standard | In distribution | |
| 4×30 Ultracongruent | In distribution | |
| 3RT | In distribution | |
| 24×100 | In distribution | |
| 7×16 Ultracongruent | In distribution | |
| 7×25 Ultracongruent | In distribution | |
| 12×200 | In distribution | |
| Distal Half 3-4 | In distribution | |
| 5×14 Ultracongruent | In distribution | |
| 3×10 Ultracongruent | In distribution | |
| Posterior Thick 5-6 | In distribution | |
| 6×35 Ultracongruent | In distribution | |
| 16×200 | In distribution | |
| 24×65 | In distribution | |
| 3×10 Standard | In distribution | |
| 3×18 Ultracongruent | In distribution | |
| Posterior Thin 3-4 | In distribution | |
| 3LT | In distribution | |
| 6×14 Standard | In distribution | |
| 3×16 Standard | In distribution | |
| 14×200 | In distribution | |
| 5×16 Ultracongruent | In distribution | |
| 3×16 Ultracongruent | In distribution | |
| Size 4 | In distribution | |
| 5×10 Standard | In distribution | |
| 10×100 | In distribution | |
| 5×20 Standard | In distribution | |
| 6×16 Ultracongruent | In distribution | |
| 12×150 | In distribution | |
| 5×18 Ultracongruent | In distribution | |
| 4×16 Standard | In distribution | |
| 4×25 Ultracongruent | In distribution | |
| 5×25 Ultracongruent | In distribution | |
| 7RT | In distribution | |
| 18×150 | In distribution | |
| 26×100 | In distribution | |
| 12×100 | In distribution | |
| 14×100 | In distribution | |
| 34/55 | In distribution | |
| Posterior Thin 5-6 | In distribution | |
| SM11-204B | In distribution | |
| 10×200 | In distribution | |
| 4×14 Ultracongruent | In distribution | |
| 6×12 Standard | In distribution | |
| 4×14 Standard | In distribution | |
| 3×12 Standard | In distribution | |
| 7×12 Ultracongruent | In distribution | |
| 4×12 Ultracongruent | In distribution | |
| 4LT | In distribution | |
| 14×150 | In distribution | |
| 3×12 Ultracongruent | In distribution | |
| 28/40 | In distribution | |
| 20×55 | In distribution | |
| 4RT | In distribution | |
| 7×30 Ultracongruent | In distribution | |
| 30/45 | In distribution | |
| 18×100 | In distribution | |
| 3×30 Ultracongruent | In distribution | |
| 7×20 Ultracongruent | In distribution | |
| Size 7 | In distribution | |
| 4×12 Standard | In distribution | |
| 3×20 Ultracongruent | In distribution | |
| 22×60 | In distribution | |
| 6RT | In distribution | |
| 5×12 Ultracongruent | In distribution | |
| 7×10 Ultracongruent | In distribution | |
| 3×35 Ultracongruent | In distribution | |
| SM11-204C | In distribution | |
| 6×14 Ultracongruent | In distribution | |
| SM11-204A | In distribution | |
| Size 3 | In distribution | |
| 3×14 Ultracongruent | In distribution | |
| Posterior Thin 7-8 | In distribution | |
| 4×35 Ultracongruent | In distribution | |
| 6×18 Standard | In distribution | |
| 26×200 | In distribution | |
| 7×20 Standard | In distribution | |
| 20×150 | In distribution | |
| 4×18 Standard | In distribution | |
| 7×16 Standard | In distribution | |
| 24×200 | In distribution | |
| Size 6 | In distribution | |
| 7LT | In distribution | |
| 10×150 | In distribution | |
| Distal Half 7-8 | In distribution | |
| 7×18 Standard | In distribution | |
| 5×16 Standard | In distribution | |
| Offset | In distribution | |
| 18×200 | In distribution | |
| 5LT | In distribution | |
| 5×10 Ultracongruent | In distribution | |
| 7×18 Ultracongruent | In distribution | |
| Size 5 | In distribution | |
| 6×10 Standard | In distribution | |
| 6×30 Ultracongruent | In distribution | |
| 4×16 Ultracongruent | In distribution | |
| 5×30 Ultracongruent | In distribution | |
| 5×14 Standard | In distribution | |
| 5RT | In distribution | |
| 24×150 | In distribution | |
| 7×35 Ultracongruent | In distribution | |
| Posterior Thick 7-8 | In distribution | |
| Distal Half 5-6 | In distribution | |
| 7×10 Standard | 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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Signal Medical Corp. | 510(k) number | 2014-09-30 | Class II | Packaging | Packaging of a device was compromised | 41 | 2016-03-14 |
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.