Intermoore Fracture Hip Stem

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

510(k) Number

K954854 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

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 Intermoore Fracture Hip Stem used for?

  The Intermoore Fracture Hip Stem is designed specifically for total hip replacement or hemiarthroplasty procedures to replace the proximal femur in cases of fractures. It provides structural support to the femur, helping to restore function and stability after surgical intervention.

• Is the Intermoore Fracture Hip Stem single-use or reusable?

  This device is supplied as a reusable surgical implant. It is intended for multiple uses in sterile operating environments, provided it undergoes proper sterilization between procedures to maintain safety and efficacy.

• What regulatory pathway does the Intermoore Fracture Hip Stem follow?

  The Intermoore Fracture Hip Stem is regulated under the FDA’s 510(k) clearance pathway (K954854) with a traditional review. It was determined to be substantially equivalent to a predicate device, adhering to FDA orthopedic standards for orthopedic implants.

• How should the Intermoore Fracture Hip Stem be stored before use?

  The device must be stored in a sterile environment to ensure its integrity before surgical use. Proper sterilization procedures must be followed as outlined in the manufacturer’s instructions to maintain sterility and prevent contamination prior to implantation.

• What product code categorizes the Intermoore Fracture Hip Stem?

  The Intermoore Fracture Hip Stem is classified under FDA product code LWJ, which identifies it as a femoral prosthesis intended for orthopedic surgical applications, including fracture repair.