Howmedica Femoral Component

• • Terminated Z-1982-2012 FDA Class II ·initiated 29 Dec 2011

  Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

Full name

Howmedica Premium Femoral Component

510(k) Number

K936127 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What is the primary function of the Howmedica Premium Femoral Component?

  This device serves as a femoral component for a hip prosthesis. It is designed with a specific proximal geometry that matches the reamer and chisel used during the preparation of the proximal metaphysis and medullary canal.

• How is the design of the femoral component structured?

  The component features three distinct sections: a distal portion that defines a central longitudinal axis, a mid-shaft portion with a generally conical shape, and a proximal portion engineered to fit the prepared medullary canal.

• What is the regulatory status of this device?

  The Howmedica Premium Femoral Component has received FDA 510(k) clearance under the number K936127. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.