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Porocoat Low Profile Metal Backed Cup

by Depuy, Inc.

510(k) K821713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821713 Date20 Aug 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Porocoat Low Profile Metal Backed Cup is an orthopedic hip cup implant designed for use in hip arthroplasty procedures. This device serves as a component of an acetabular system to facilitate joint replacement.

This device is identified under FDA 510(k) clearance K821713. It is manufactured by Depuy, Inc. and is categorized under product code JDI.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Porocoat Low Profile Metal Backed Cup?

    The Porocoat Low Profile Metal Backed Cup is an orthopedic hip cup implant designed to function as a component of an acetabular system during hip arthroplasty procedures to facilitate joint replacement.

  • What is the regulatory status of this hip cup implant?

    This device is manufactured by Depuy, Inc. and is identified under FDA 510(k) clearance number K821713, which was granted on August 20, 1982.

  • How is this device classified for regulatory purposes?

    The device is categorized under product code JDI, which is associated with orthopedic hip arthroplasty components reviewed by the Orthopedic advisory committee.