F-220 Press-Fit Femoral Hip Stem System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935990 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SN

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See all devices from Implex Corp. →

• What types of hip replacement procedures is the F-220 Press-Fit Femoral Hip Stem System intended for?

  The F-220 Press-Fit Femoral Hip Stem System is designed specifically for total hip arthroplasty, where it serves as the femoral component to replace the femoral head and neck. It is intended for press-fit fixation within the femoral canal, providing stability through its geometric design without the need for bone cement or porous coatings. This makes it suitable for primary hip replacements where a secure, non-cemented fixation is desired.

• Is the F-220 Press-Fit Femoral Hip Stem System intended for single-use or can it be reused?

  The F-220 Press-Fit Femoral Hip Stem System is explicitly described as a reusable surgical implant. Since it is intended for use in orthopedic procedures under sterile conditions, it must be handled, cleaned, and sterilized according to standard orthopedic implant protocols to ensure safety and functionality for repeated use.

• How should the F-220 Press-Fit Femoral Hip Stem System be stored, and what considerations should be taken into account?

  The F-220 Press-Fit Femoral Hip Stem System must be stored and handled in compliance with standard orthopedic implant protocols, which typically include maintaining sterility, protecting from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Since it is reusable, proper cleaning, sterilization, and storage procedures are critical to prevent damage or degradation before reuse in subsequent procedures.

• What regulatory pathway was followed for the FDA clearance of the F-220 Press-Fit Femoral Hip Stem System?

  The F-220 Press-Fit Femoral Hip Stem System received FDA clearance through a 510(k) submission, specifically under the traditional review pathway. It was classified under product code MEH (Orthopedic Prosthesis, Hip, Femoral Component) and was determined to be substantially equivalent for some indications by the Orthopedic (OR) Advisory Committee. The clearance was granted on July 13, 1994, following a review process initiated on December 14, 1993.