Line Extension for Kirschner Performance Total Knee System, Porous Coated

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K933843 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Dosimetric Release of Gamma Radiation

  Class II

  FDA 510(k) K832211 Active Cleared 29 Sep 1983

• Austin Moore Hip Prosthesis

  Not classified

  FDA 510(k) K863896 Active Cleared 19 Nov 1986

• Dimension Total Hip Prosthesis

  Class II

  FDA 510(k) K853333 Active Cleared 3 Sep 1985

• Compression System

  Class II

  FDA 510(k) K831076 Active Cleared 28 Apr 1983

• Wire & Steinman Pins

  Class II

  FDA 510(k) K831005 Active Cleared 18 May 1983

• Kirschner(R) Modular II-C(Tm) Total Shoulder System

  Class II

  FDA 510(k) K940537 Active Cleared 29 Aug 1995

See all devices from Kirschner Medical Corp. →

• What is the Line Extension for Kirschner Performance Total Knee System, Porous Coated used for?

  This device is designed specifically for total knee arthroplasty procedures. Its porous-coated surface promotes bone integration, providing enhanced structural support during knee replacement surgeries. The extension maintains compatibility with the existing Kirschner Performance Total Knee System, ensuring seamless surgical integration.

• Is this device intended for single-use or reusable applications?

  The Line Extension for Kirschner Performance Total Knee System is intended for use according to institutional protocols, which may dictate either single-use or reusable applications. Institutions must follow their established protocols for handling and reprocessing orthopedic implants to ensure safety and efficacy.

• How should this device be stored and handled?

  Storage and handling of this device follow standard orthopedic implant protocols. Proper storage conditions, such as clean and dry environments, should be maintained to preserve sterility and functionality. Always adhere to manufacturer guidelines and institutional policies for optimal performance and safety.

• Is MRI compatibility information provided for this device?

  The provided data does not explicitly state whether this device is MRI-safe or unsafe. Orthopedic implants should be evaluated for MRI compatibility based on their material composition and the specific surgical context. Consult manufacturer documentation or clinical guidelines for MRI-related considerations.

• What regulatory pathway was used for this device’s clearance?

  This device received FDA clearance under the Traditional 510(k) pathway, classified under the Orthopedic Advisory Committee (OR). The clearance number is K933843, and it was determined to be substantially equivalent to a predicate device. This classification ensures it meets regulatory standards for safety and effectiveness in its intended use.