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AML Proximal Porocoat Femoral Hip

by Depuy, Inc.

510(k) K852198

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 NumberK852198 Date22 Aug 1985ClearedStatusActive

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The AML Proximal Porocoat Femoral Hip is an orthopedic implant device used for hip replacement procedures. It is designed to replace the femoral head and neck portion of the hip joint, providing a prosthetic solution for patients requiring hip arthroplasty.

This device is supplied as a single-use implant and is not MRI safe. It is manufactured by Depuy, Inc. and has received FDA 510(k) clearance with the product code LPH. The device is stored according to the manufacturer's instructions and is authorized for use in the United States.

Other devices from Depuy, Inc.

See all devices from Depuy, Inc. →

Questions

AI-generated answers, 23 Sep 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 AML Proximal Porocoat Femoral Hip used for?

    The AML Proximal Porocoat Femoral Hip is an orthopedic implant device designed to replace the femoral head and neck portion of the hip joint, providing a prosthetic solution for patients requiring hip arthroplasty procedures.

  • Is the AML Proximal Porocoat Femoral Hip reusable or MRI safe?

    This device is supplied as a single-use implant and is not MRI safe. It is designed for one-time use only and should not be used in MRI environments due to potential safety concerns.

  • What regulatory approvals does the AML Proximal Porocoat Femoral Hip have?

    The device has received FDA 510(k) clearance with the product code LPH. It is manufactured by Depuy, Inc. and is authorized for use in the United States, where it is stored according to the manufacturer's instructions.

  • What are the key specifications of the AML Proximal Porocoat Femoral Hip?

    The device is classified under product code LPH and received traditional 510(k) clearance in 1985. It was reviewed by the Orthopedic advisory committee and determined to be substantially equivalent to predicate devices for hip replacement procedures.