Porocoat Standard Metal Backed Cup

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K821714 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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 Porocoat Standard Metal Backed Cup primarily used for in orthopedic surgery?

  The Porocoat Standard Metal Backed Cup is designed specifically for hip replacement surgery as part of an orthopedic procedure. Its porous coating on a metal backing promotes osseointegration, which helps create a stable connection between the cup and the pelvic bone, ensuring long-term fixation.

• Is this device intended for single-use or can it be reused in multiple surgeries?

  The Porocoat Standard Metal Backed Cup is explicitly intended for single-use in surgical settings. This is a standard practice for orthopedic implants to ensure patient safety and sterility, preventing cross-contamination between procedures.

• How is the Porocoat Standard Metal Backed Cup supplied, and what does that mean for surgical planning?

  The device is supplied sterile, meaning it is pre-packaged and ready for immediate use in the operating room without additional sterilization. This ensures compliance with surgical protocols and reduces the risk of contamination during surgery.

• What regulatory pathway was followed for FDA clearance of this device, and when was it first authorized?

  The Porocoat Standard Metal Backed Cup received FDA 510(k) clearance under the traditional review pathway, with a decision date of August 20, 1982. It was first authorized in 1982 and falls under product code JDI for orthopedic implants.