Natural-Knee II Patellofemoral Joint Prosthesis

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

510(k) Number

K002356 ↗

FDA Product Code

KRR

Device Class

Class II

Regulation

21 CFR Part 888.3540

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Sulzer Orthopedics Converge Acetabular System

  Class II

  FDA 510(k) K012961 Active Cleared 18 Oct 2001

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

See all devices from Sulzer Orthopedics, Inc. →

• What types of knee issues is the Natural-Knee II Patellofemoral Joint Prosthesis designed to address in patients?

  The Natural-Knee II Patellofemoral Joint Prosthesis is specifically designed to address patellofemoral joint issues such as primary patellofemoral arthritis or chondromalacia. It is intended for use in orthopedic surgery to restore function and stability to the patellofemoral joint in patients experiencing degenerative or damaged cartilage in this area.

• How is the Natural-Knee II Patellofemoral Joint Prosthesis secured in place during surgery?

  The prosthesis is secured using bone cement, which is applied during surgery to firmly attach the implant to the patient’s femur and patella. This cemented fixation ensures stability and longevity of the implant.

• Is the Natural-Knee II Patellofemoral Joint Prosthesis intended for single-use or can it be reused?

  The Natural-Knee II Patellofemoral Joint Prosthesis is supplied as a sterile, single-use implant. It is not designed for reuse after surgical implantation.

• What range of sizes is available for the Natural-Knee II Patellofemoral Joint Prosthesis to accommodate different patient anatomies?

  Multiple femoral and tibial component sizes are available to fit varying patient anatomies. The exact sizes are listed in the provided FEI numbers (e.g., 3005706667, 1000114185, etc.), which correspond to specific component dimensions tailored for different knee structures.

• What regulatory pathway was followed for the FDA clearance of the Natural-Knee II Patellofemoral Joint Prosthesis?

  The Natural-Knee II Patellofemoral Joint Prosthesis received FDA clearance through the 510(k) pathway, specifically under the traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device and was reviewed by the Orthopedic (OR) Advisory Committee.