Profix Posterior-Stabilized Knee System

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

510(k) Number

K954909 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• Hydrocell Nasal and Sinus Packs

  Class I

  FDA 510(k) K954491 Active Cleared 15 Nov 1995

• Black Oval-Top Torp/Porp

  Class II

  FDA 510(k) K934107 Active Cleared 8 Jun 1994

• Profix Conforming Plus Tibial Insert

  Class II

  FDA 510(k) K946236 Active Cleared 6 Jul 1995

• Epistaxis Nasal Balloon Catheter

  Class I

  FDA 510(k) K921199 Active Cleared 8 Jul 1992

• Geri Total Hip System

  Class II

  FDA 510(k) K905186 Active Cleared 15 Feb 1991

• Rihards Titanium Half Pin

  Class II

  FDA 510(k) K920024 Active Cleared 21 Jan 1992

See all devices from Smith & Nephew Richards, Inc. →

• What is the Profix Posterior-Stabilized Knee System used for?

  This system is designed specifically for total knee arthroplasty (knee replacement surgery) in patients suffering from degenerative joint disease or traumatic knee injuries. Its posterior-stabilized design improves joint stability and mimics natural knee mechanics, helping restore function and mobility. It is intended for use by trained orthopedic surgeons in surgical settings.

• How is the Profix Posterior-Stabilized Knee System supplied?

  The system is supplied as a sterile, single-use implant. This ensures safety and reduces the risk of infection or cross-contamination during surgery. Proper aseptic handling and adherence to manufacturer guidelines are essential to maintain sterility before implantation.

• Is the Profix Posterior-Stabilized Knee System reusable?

  No, the Profix Posterior-Stabilized Knee System is intended for single-use only. Single-use implants are designed to be used once per patient and then discarded. This approach minimizes infection risks and ensures compliance with medical best practices for orthopedic implants.

• What components are included in the Profix Posterior-Stabilized Knee System?

  The system includes femoral implants, tibial implants, and polyethylene inserts. These components work together to replicate the natural mechanics of the knee joint, providing stability and restoring function in patients undergoing total knee replacement.

• How should the Profix Posterior-Stabilized Knee System be stored?

  Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Typically, this involves keeping the system in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Proper storage ensures the implant remains ready for use when needed in surgical procedures.