New Jersey Modular Femoral Hip

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

510(k) Number

K853655 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

  Class II

  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →

• What is the New Jersey Modular Femoral Hip used for?

  It is a femoral component prosthesis designed for use in hip arthroplasty procedures to replace the femoral part of the hip joint during orthopedic surgery.

• Is the New Jersey Modular Femoral Hip reusable or single-use?

  It is supplied as a reusable implant component, meaning it can be sterilized and used multiple times in clinical settings as part of hip replacement systems.

• How was the New Jersey Modular Femoral Hip cleared for market?

  It received FDA 510(k) clearance under submission K853655, where it was determined to be substantially equivalent to a predicate device for some indications in hip arthroplasty.