Hofmann Knee

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

510(k) Number

K853991 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Drg Cemeted Stem

  Class II

  FDA 510(k) K920003 Active Cleared 13 Mar 1992

• Intermedics Power Broach Impactor

  Class I

  FDA 510(k) K895121 Active Cleared 11 Sep 1989

• Intermedics High Tibial Osteotomy System

  Class II

  FDA 510(k) K892228 Active Cleared 6 Oct 1989

• Ioi Bipolar Prosthesis

  Class II

  FDA 510(k) K873815 Active Cleared 28 Oct 1987

• Select(R) Shoulder All Poly Glenoid

  Class II

  FDA 510(k) K935802 Active Cleared 22 May 1995

• Zweymueller Sl Femoral Hip Stem

  Class II

  FDA 510(k) K962101 Active Cleared 19 Aug 1996

See all devices from Intermedics Orthopedics →

• What is the primary function of the Hofmann Knee?

  The Hofmann Knee is an orthopedic medical device intended for use in knee replacement procedures. It serves as a prosthetic component designed to restore joint function and mobility for the patient.

• How is the Hofmann Knee identified for regulatory purposes?

  This device is identified by the FDA 510(k) clearance number K853991. It was submitted by Intermedics Orthopedics and is classified under the product code JWH.

• What is the regulatory status of this prosthetic device?

  The Hofmann Knee received FDA 510(k) clearance on February 21, 1986, under the decision description of Substantially Equivalent. This indicates that the device was determined to be substantially equivalent to a predicate device for the purpose of the 510(k) submission process.