Meduloc Intramedullary Fracture Fixation (IFF) System
Meduloc Intramedullary Fracture Fixation System stabilizes small long-bone fractures using a wire, bone anchor and locking screw. Different implant sizes accommodate the patient's anatomy.…
Meduloc Intramedullary Fracture Fixation System stabilizes small long-bone fractures using a wire, bone anchor and locking screw. Different implant sizes accommodate the patient’s anatomy.
The intramedullary wire is made from nitinol, while the bone anchor and locking screw are made from Ti-6Al-4V titanium alloy. The wire lies within the bone’s medullary space as part of the fixation construct.
Listed Item
Sterile Meduloc IFF System Implant Kit (2.0L)
Implant Kit
The system includes ancillary instruments for placing its components. Wire, anchor and locking screw are supplied as a coordinated implant system rather than a single standalone fastener. All system elements are supplied sterile after gamma sterilization and are intended for single use in adult or pediatric fracture fixation.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Meduloc, United States |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K250316 |
| Record published | 2026-01-14 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PKG-90-IFF-200015 | In distribution | |
| PKG-90-IFF-201520 | In distribution | |
| PKG-90-IFF-201525 | In distribution | |
| PKG-90-IFF-201025 | In distribution | |
| PKG-90-IFF-200020 | In distribution | |
| PKG-90-IFF-200030 | In distribution | |
| PKG-90-IFF-200035 | In distribution | |
| PKG-90-IFF-200520 | In distribution | |
| PKG-90-IFF-200025 | In distribution | |
| PKG-90-IFF-201015 | In distribution | |
| PKG-90-IFF-200515 | In distribution | |
| PKG-90-IFF-200530 | In distribution | |
| PKG-90-IFF-201020 | In distribution | |
| PKG-90-IFF-201530 | In distribution | |
| PKG-90-IFF-200535 | In distribution | |
| PKG-90-IFF-201030 | In distribution | |
| PKG-90-IFF-200525 | In distribution | |
| PKG-90-IFF-201515 | In distribution | |
| PKG-90-IFF-201035 | In distribution | |
| PKG-90-IFF-201535 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250316 | 2025-10-29 |
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.