F-24 Femoral Hip Prosthesis

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

510(k) Number

K901687 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• H.N. Metal Backed Acetabular Cup, Noncemented

  Class III

  FDA 510(k) K901626 Active Cleared 14 Aug 1990

• Blood Pressure Device, 400 Series

  Class II

  FDA 510(k) K781906 Active Cleared 16 Nov 1978

• F-20 Cemented Metal-Backed Acetabular Cup

  Class II

  FDA 510(k) K901451 Active Cleared 31 Aug 1990

• Lifeguard

  Class II

  FDA 510(k) K022755 Active Cleared 24 Sep 2002

• F-19 Total Hip Prosthesis

  Class II

  FDA 510(k) K903234 Active Cleared 10 Oct 1990

• Anesthesia Breathing Circuits

  Class I

  FDA 510(k) K900428 Active Cleared 17 Aug 1990

See all devices from Med-Tek Corp. →

• What types of patients is the F-24 Femoral Hip Prosthesis intended to help, and how does it improve their condition?

  The F-24 Femoral Hip Prosthesis is designed for patients suffering from degenerative joint conditions, fractures, or other pathologies affecting the hip joint that require total hip arthroplasty. It replaces the damaged femoral head and neck, restoring joint function and mobility to alleviate pain and enhance movement, thereby improving the patient’s quality of life.

• Is the F-24 Femoral Hip Prosthesis reusable or intended for single-use, and how should it be stored?

  The F-24 Femoral Hip Prosthesis is intended for single-use in controlled surgical environments. While specific storage instructions aren’t detailed beyond standard sterile surgical protocols, it is supplied sterile, so it should be handled and stored according to best practices for maintaining sterility until use.

• How was the F-24 Femoral Hip Prosthesis evaluated by the FDA, and what does its classification under product code LWJ mean?

  The F-24 Femoral Hip Prosthesis received a Traditional 510(k) clearance (K901687) in 1990, deemed *Substantially Equivalent* to a predicate device by the FDA’s Orthopedic (OR) Advisory Committee. The product code LWJ categorizes it as a femoral component for total hip replacement, confirming its intended use in orthopedic surgery.

• Who should I contact at Med-Tek Corp. if I need further details about the F-24 Femoral Hip Prosthesis?

  For inquiries about the F-24 Femoral Hip Prosthesis, you can reach Med-Tek Corp. at their address: 6535 E. 82nd St., Suite 215, Indianapolis, IN 46250. The contact person listed is Kenneth Epling, though you may verify current contact details through their official channels.