Megasystem C
Stem Components,Coupling Component for total femur replacement
9manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151008 |
| Record published | 2015-11-01 |
| Record revised | 2023-02-03 (version 4) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-8503/26 | CCD 126°, 65mm | In distribution |
| 15-8522/70 | Diameter=16mm, Length=120mm | In distribution |
| 15-8512/84 | In distribution | |
| 15-8522/65 | In distribution | |
| 15-8522/02 | Length=30mm | In distribution |
| 15-8512/85 | In distribution | |
| 15-8522/24 | In distribution | |
| 15-8502/66 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051826 | 2005-11-18 |
Recalls Naming This Product
14 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 44 units (1 US, 43 OUS) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 3 units |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 49 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 31 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 1 unit (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 7 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 4 units (all OUS) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 8 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 7 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 4 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 2 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 1 unit (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2026-01-12 | Class II | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | 3 units (OUS only) |
| Waldemar Link GmbH & Co. KG | 510(k) number | 2025-11-10 | Class II | Process control | The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. | 18 units |
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.