TrabecuLink Femoral Cones
TrabecuLink Femoral Cones are metal augments used to fill large bone defects around the femoral side of a knee replacement. They support and stabilize the remaining bone structure while…
TrabecuLink Femoral Cones are metal augments used to fill large bone defects around the femoral side of a knee replacement. They support and stabilize the remaining bone structure while providing an interface for the femoral prosthesis.
The cones are made by electron-beam melting titanium alloy powder. A dense inner surface is surrounded by a porous, trabecular outer structure, giving the inner and outer surfaces different fixation roles.
Listed Item
TrabecuLink Femoral Cones / 3-zones right
Two Fixation Interfaces
The outer cone surface provides cementless fixation to bone, while the mating knee endoprosthesis is cemented to the cone. The cones are designed for the LINK Endo-Model Standard, Modular or Porex-coated systems and the Endo-Model SL system.
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 | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| 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 | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K201364 |
| Record published | 2021-01-12 |
| Record revised | 2023-02-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-3992/04 | In distribution | |
| 15-3994/04 | In distribution | |
| 15-3994/05 | In distribution | |
| 15-3997/01 | In distribution | |
| 15-3993/02 | In distribution | |
| 15-3995/02 | In distribution | |
| 15-3998/01 | In distribution | |
| 15-3995/03 | In distribution | |
| 15-3992/05 | In distribution | |
| 15-3994/01 | In distribution | |
| 15-3998/03 | In distribution | |
| 15-3993/01 | In distribution | |
| 15-3997/03 | In distribution | |
| 15-3996/03 | In distribution | |
| 15-3996/02 | In distribution | |
| 15-3991/01 | In distribution | |
| 15-3991/03 | In distribution | |
| 15-3995/01 | In distribution | |
| 15-3992/02 | In distribution | |
| 15-3992/07 | In distribution | |
| 15-3992/06 | In distribution | |
| 15-3994/07 | In distribution | |
| 15-3996/01 | In distribution | |
| 15-3991/02 | In distribution | |
| 15-3992/01 | In distribution | |
| 15-3994/03 | In distribution | |
| 15-3993/03 | In distribution | |
| 15-3994/06 | In distribution | |
| 15-3994/02 | In distribution | |
| 15-3998/02 | In distribution | |
| 15-3997/02 | In distribution | |
| 15-3992/03 | 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 |
|---|---|
| K201364 | 2020-07-17 |
| K200113 | 2020-03-18 |
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.