APR Femoral Hip Component

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

510(k) Number

K930812 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

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 APR Femoral Hip Component used for?

  The APR Femoral Hip Component is designed specifically for total hip arthroplasty, replacing the damaged or diseased femoral head and neck in patients suffering from degenerative joint disease, fractures, or other conditions requiring hip replacement. It interfaces with acetabular components to restore joint function and improve mobility, providing a durable, load-bearing solution for long-term use.

• Is the APR Femoral Hip Component single-use or reusable?

  The APR Femoral Hip Component is supplied as a single-use, sterile implant. This ensures patient safety by preventing cross-contamination and maintaining sterility during surgical procedures, adhering to aseptic technique requirements in orthopedic settings.

• What sizes are available for the APR Femoral Hip Component?

  The APR Femoral Hip Component comes in various sizes to accommodate different patient anatomies. Exact specifications for sizing are detailed in the original FDA submission and should be referenced during preoperative planning to ensure proper fit and function.

• How should the APR Femoral Hip Component be stored?

  Since the APR Femoral Hip Component is sterile and single-use, it must be stored in its original packaging under clean, dry conditions to preserve sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight, and follow manufacturer guidelines to maintain integrity until surgical use.

• What regulatory approval does the APR Femoral Hip Component hold?

  The APR Femoral Hip Component holds FDA 510(k) clearance (K930812) as a Class II Orthopedic device, classified as substantially equivalent under traditional review. This approval confirms its compliance with U.S. regulatory standards for use in total hip arthroplasty procedures.