MEC Intramedullary Rod
by Pfizer Inc. 510(k)
Active
510(k) K850441
Overview
The MEC Intramedullary Rod is an orthopedic fixation device classified as a Rod, Fixation, Intramedullary and Accessories (product code HSB). It is designed for internal stabilization of long bone fractures by insertion into the medullary cavity, providing structural support during the healing process.
This device is supplied as a reusable surgical implant and is intended for use in orthopedic procedures under sterile conditions. It is regulated under FDA 510(k) clearance (K850441) and falls under Class II – Special Controls. No additional regulatory status beyond the provided data is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850441 | Date19 Apr 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HSB
- FDA applicant
- Pfizer, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pfizer Inc.
Questions
What types of long bone fractures is the MEC Intramedullary Rod designed to stabilize, and how does it work?
The MEC Intramedullary Rod is designed for internal stabilization of long bone fractures by being inserted into the medullary cavity of the bone. It provides structural support to help align and maintain the fracture site during the healing process, ensuring proper bone alignment and stability. It is intended for use in orthopedic procedures where internal fixation is required.
Is the MEC Intramedullary Rod intended for single-use or can it be reused in multiple procedures?
The MEC Intramedullary Rod is explicitly described as a reusable surgical implant. It is intended for use in multiple procedures under sterile conditions, meaning it must be properly cleaned, sterilized, and handled according to medical device reprocessing protocols between uses.
How is the MEC Intramedullary Rod regulated, and what does its classification mean for its use?
The MEC Intramedullary Rod is regulated under the FDA’s 510(k) clearance process (K850441) and falls under Class II – Special Controls for orthopedic fixation devices. This classification means it has been determined to be substantially equivalent to a legally marketed device already on the market, ensuring it meets established safety and performance standards for internal bone stabilization.
What kind of sterility precautions should be taken when using the MEC Intramedullary Rod in surgery?
Since the MEC Intramedullary Rod is intended for sterile surgical use, it must be handled as a sterile implant. Before insertion, it should be properly sterilized (e.g., via autoclave or ethylene oxide) and maintained in a sterile packaging or environment until the procedure begins. Reuse requires adherence to strict reprocessing protocols to ensure sterility between cases.
What product code does the MEC Intramedullary Rod fall under, and what does that indicate about its intended use?
The MEC Intramedullary Rod is classified under product code HSB, which corresponds to Rod, Fixation, Intramedullary and Accessories. This classification confirms its primary purpose is for internal fixation of long bones via intramedullary placement, distinguishing it from external fixation devices or other orthopedic hardware.