Balanced Knee Revision System
Large Cone Non-Flared 65mm M-L 38mm A-P
12manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K181569 |
| Record published | 2018-11-06 |
| Record revised | 2024-02-28 (version 2) |
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 |
| Sizes | Height 10 to 59.5 mm; width 22 to 60 mm; length 17.8 to 68 mm; outer diameter 10.1 to 36 mm; lumen/inner diameter 19 to 21 mm; angle 5 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 562-4200 | In distribution | |
| 561-5258 | Height 59.5 mm | In distribution |
| 561-0510 | Angle 5 ° | In distribution |
| 562-5040 | Width 40 mm | In distribution |
| 562-4400 | In distribution | |
| 562-7135 | Height 15 mm | In distribution |
| 562-7036 | Height 20 mm | In distribution |
| 561-5240 | Length 40 mm | In distribution |
| 562-5268 | Height 50.5 mm | In distribution |
| 562-5252 | Length 52 mm | In distribution |
| 561-0010 | Outer Diameter 10.1 mm | In distribution |
| 562-7034 | Outer Diameter 34 mm | In distribution |
| 561-5246 | Width 22 mm | In distribution |
| 562-5235 | Length 35 mm | In distribution |
| 562-7765 | Width 37.1 mm | In distribution |
| 562-4310 | Height 10 mm | In distribution |
| 562-5230 | Width 26 mm | In distribution |
| 562-5260 | Height 50.5 mm | In distribution |
| 562-5060 | Width 60 mm | In distribution |
| 562-4410 | Height 10 mm | In distribution |
| 562-5240 | Length 40 mm | In distribution |
| 561-0520 | In distribution | |
| 562-4100 | In distribution | |
| 561-5252 | Height 59.5 mm | In distribution |
| 562-5245 | Length 45 mm | In distribution |
| 561-5231 | Height 59.5 mm | In distribution |
| 562-7747 | Length 47 mm | In distribution |
| 561-5234 | Length 34 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253161 | 2025-12-19 |
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.