Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Tapered Junction Box 5 Degree Stem Trial
12manufacturers in China registered for this device type
73catalogue 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 | 2020-10-30 |
| Record revised | 2024-08-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 23 to 68 mm; width 23 to 38 mm; outer diameter 31 to 36 mm; height 10 mm; angle 5 ° |
| Distribution end date | 2024-08-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 662-4200 | In distribution | |
| 662-7302 | In distribution | |
| 662-4310 | Height 10 mm | In distribution |
| 662-7004 | In distribution | |
| 662-7305 | In distribution | |
| 661-5046 | Length 46 mm | In distribution |
| 662-7202-65 | Width 38 mm | In distribution |
| 662-7000-31A | Outer Diameter 31 mm | In distribution |
| 662-7003 | In distribution | |
| 662-7102-32 | Width 32 mm | In distribution |
| 662-7200-58A | Length 58 mm | In distribution |
| 662-4001 | In distribution | |
| 661-5040 | Length 40 mm | In distribution |
| 662-7200-52A | Width 33 mm | In distribution |
| 662-7001 | In distribution | |
| 662-7002 | In distribution | |
| 662-4100 | In distribution | |
| 662-7006 | In distribution | |
| 662-4410 | Height 10 mm | In distribution |
| 662-7000-36A | Outer Diameter 36 mm | In distribution |
| 662-7202-00 | In distribution | |
| 662-4300 | In distribution | |
| 662-7202-52 | Length 52 mm | In distribution |
| 662-5052 | Width 30 mm | In distribution |
| 662-7200-65A | Length 65 mm | In distribution |
| 662-7000-34 | Outer Diameter 34 mm | In distribution |
| 662-7007 | In distribution | |
| 662-4700 | In distribution | |
| 662-7100-32A | Width 32 mm | In distribution |
| 662-7202-58 | Width 35 mm | In distribution |
| 662-7002-34 | Outer Diameter 34 mm | In distribution |
| 662-4510 | Height 10 mm | In distribution |
| 662-7100-32 | Length 32 mm | In distribution |
| 662-7301 | In distribution | |
| 662-4600 | In distribution | |
| 661-5052 | Length 52 mm | In distribution |
| 662-7000-34A | Outer Diameter 34 mm | In distribution |
| 662-7202-47 | Length 47 mm | In distribution |
| 662-5040 | Width 28 mm | In distribution |
| 661-0512 | Angle 5 ° | In distribution |
| 662-7102-35 | Length 25 mm | In distribution |
| 662-7000-36 | Outer Diameter 36 mm | In distribution |
| 661-5031 | Length 31 mm | In distribution |
| 662-7303 | In distribution | |
| 662-5045 | Length 45 mm | In distribution |
| 662-7000-31 | Outer Diameter 31 mm | In distribution |
| 662-7200-47A | Length 47 mm | In distribution |
| 662-4400 | In distribution | |
| 661-5252 | Length 52 mm | In distribution |
| 662-7304 | In distribution | |
| 662-5060 | Width 31 mm | In distribution |
| 662-4500 | In distribution | |
| 662-7306 | In distribution | |
| 662-7307 | In distribution | |
| 662-7005 | In distribution | |
| 661-5258 | Length 58 mm | In distribution |
| 661-5246 | Length 46 mm | In distribution |
| 661-5034 | Length 34 mm | In distribution |
| 661-5240 | Length 40 mm | In distribution |
| 661-5234 | Length 34 mm | In distribution |
| 662-7100-35 | Length 35 mm | In distribution |
| 661-5231 | Length 31 mm | In distribution |
| 662-7100-35A | Length 25 mm | In distribution |
| 661-0510 | Angle 5 ° | In distribution |
| 662-7002-31 | Outer Diameter 31 mm | In distribution |
| 662-7002-36 | Outer Diameter 36 mm | In distribution |
| 662-5252 | Length 52 mm | Withdrawn |
| 662-5035 | Length 35 mm | Withdrawn |
| 662-5240 | Length 40 mm | Withdrawn |
| 662-5268 | Length 68 mm | Withdrawn |
| 662-5245 | Width 29 mm | Withdrawn |
| 662-5030 | Length 30 mm | Withdrawn |
| 662-5260 | Length 60 mm | Withdrawn |
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.