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PPC Hip Stem Component

by Implantology Corp.

510(k) K915385

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)SN Traditional NumberK915385 Date17 May 1993DecidedStatusActive

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  • Withdrawn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
JDG
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SN

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 PPC Hip Stem Component is a prosthesis for the femoral component of a hip joint, designed to be cemented in place. It is a metal implant used in orthopedic surgery to replace the femoral head and neck portion of the hip joint.

This device is supplied as a single-use implant and is not MRI safe. It is authorized under FDA 510K clearance with product code JDG and is classified as a Class II device. The device is stored according to the manufacturer's specifications and requires proper handling and sterilization before implantation.

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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 PPC Hip Stem Component used for?

    The PPC Hip Stem Component is a metal prosthesis designed to replace the femoral head and neck portion of the hip joint in orthopedic surgery. It is specifically designed to be cemented in place as part of a hip joint replacement procedure.

  • How is the PPC Hip Stem Component supplied and is it reusable?

    The PPC Hip Stem Component is supplied as a single-use implant, meaning it is intended for one patient only and should not be reused. It requires proper handling and sterilization before implantation according to the manufacturer's specifications.

  • What are the storage requirements for the PPC Hip Stem Component?

    The PPC Hip Stem Component must be stored according to the manufacturer's specifications. While the exact storage conditions aren't detailed in the provided information, it should be kept in its original packaging in a controlled environment until ready for sterilization and implantation.

  • Is the PPC Hip Stem Component MRI safe?

    No, the PPC Hip Stem Component is not MRI safe. This means patients with this implant should not undergo MRI scans as the metal components could interfere with the imaging process and potentially cause safety hazards.

  • What is the regulatory classification of the PPC Hip Stem Component?

    The PPC Hip Stem Component is authorized under FDA 510K clearance with product code JDG and is classified as a Class II device. It has been determined to be substantially equivalent for some indications in orthopedic surgery.