Modification to Provident Hip System

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

510(k) Number

K002796 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

  Class II

  FDA 510(k) K173875 Active Cleared 19 Jan 2018

• Protract Press Fit Hip Stem

  Class II

  FDA 510(k) K003447 Active Cleared 15 Dec 2000

• Proform Cemented Femoral Component

  Class II

  FDA 510(k) K951083 Active Cleared 22 May 1995

• Dual Taper Wedge Pressed Fit Femoral Component

  Class II

  FDA 510(k) K953268 Active Cleared 17 Jan 1996

• Proven Knee System

  Class II

  FDA 510(k) K000113 Active Cleared 4 Apr 2000

• Stelkast Bipolar System

  Class II

  FDA 510(k) K972961 Active Cleared 4 Nov 1997

See all devices from Stelkast Company →

• What is the Modification to Provident Hip System used for?

  The Modification to Provident Hip System is a prosthesis designed for orthopedic use, intended to replace damaged or diseased hip joints. It is a semi-constrained, metal/polymer, uncemented hip prosthesis that modifies the original Provident Hip System to address joint deterioration or injury.

• How is the Modification to Provident Hip System supplied and is it single-use or reusable?

  The device is supplied as either a single-use or reusable product, depending on the specific configuration. This flexibility allows healthcare providers to select the appropriate version based on clinical needs and institutional reprocessing capabilities, with reuse contingent on proper cleaning and sterilization protocols.

• Is the Modification to Provident Hip System MRI conditional and what storage conditions are required?

  Yes, the device is MRI conditional, meaning it can be safely used in magnetic resonance imaging environments under specified conditions. It requires proper storage conditions to maintain integrity, though specific temperature or humidity details are not provided in the data; users should follow manufacturer guidelines for storage to ensure safety and performance.