Natural-Hip System Porous Stem With Ha/Csti

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

510(k) Number

K970300 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

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 Natural-Hip System Porous Stem With Ha/Csti used for?

  The Natural-Hip System Porous Stem With Ha/Csti is used to replace the anatomy of the femur in cases of total hip or hemi-hip replacement, allowing for press-fit application due to its porous stem design.

• Is the Natural-Hip System Porous Stem With Ha/Csti supplied sterile?

  The description does not explicitly state that the device is supplied sterile, but it is intended for use in orthopedic procedures, suggesting that it would be provided in a sterile or sterilizable condition.

• What is the regulatory status of the Natural-Hip System Porous Stem With Ha/Csti?

  The device has been authorized under FDA 510K clearance, with the reference number K970300, indicating that it has been found to be substantially equivalent to a predicate device.