Endo-Model Knee System – Instruments
Orthopaedic chisel - Endo Model Rotational and Hinge Knee System
4manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | HWP |
| Device type | Punch, Femoral Neck |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-04 |
| Record revised | 2025-02-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 151-223/03 | In distribution | |
| 151-223/00 | In distribution | |
| 151-208/02 | In distribution | |
| 151-208/03 | In distribution | |
| 151-223/01 | In distribution | |
| 99-0036/44 | In distribution | |
| 151-208/00 | In distribution | |
| 151-208/01 | In distribution | |
| 151-223/02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Innomed, Inc. | Innomed, Inc. | 17 |
| LinkSymphoKnee – Instruments | Waldemar Link GmbH & Co. KG | 10 |
| MP Tibial Tray Cruciate Punch | Biomet Orthopedics | 7 |
| U2 Total Knee System | United Orthopedic Corp. | 7 |
| Microplasty | Biomet Orthopedics | 4 |
| Millennium | Avalign Technologies, Inc. | 3 |
| AGC Modular Tibial II | Biomet Orthopedics | 3 |
| Lineage | Microport Orthopedics Inc. | 3 |
| U2™ Knee | United Orthopedic Corp. | 3 |
| Vanguard(TM) Microplasty(R) | Biomet Orthopedics | 3 |
| Maxim FIN Broach Tibial Punch | Biomet Orthopedics | 3 |
| Vanguard(TM) | Biomet Orthopedics | 2 |
Showing 12 of 42. All products under Punch, Femoral Neck
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.