Skip to content

Forged Cemented Stem

by Encore Orthopedics, Inc.

510(k) K952191

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 NumberK952191 Date17 Jul 1995ClearedStatusActive

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  • Withdrawn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, 22 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 Forged Cemented Stem is an orthopedic device. It is a type of hip replacement prosthesis used in total or hemi-hip arthroplasty procedures.

The device is supplied by Encore Orthopedics, Inc. and has FDA 510K clearance. It is available with a product code of JDI and has a specific size, such as 9mm. The device is intended for use in patients with noninflammatory degenerative joint disease, rheumatoid arthritis, and other conditions.

Other devices from Encore Orthopedics, Inc.

See all devices from Encore Orthopedics, Inc. →

Questions

AI-generated answers, 22 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 Forged Cemented Stem used for?

    The Forged Cemented Stem is used in total or hemi-hip arthroplasty procedures for patients with noninflammatory degenerative joint disease, rheumatoid arthritis, and other conditions, as a type of hip replacement prosthesis.

  • What size options are available for the Forged Cemented Stem?

    The Forged Cemented Stem is available in specific sizes, such as 9mm, to accommodate different patient needs.

  • Is the Forged Cemented Stem supplied sterile?

    The device data does not explicitly state that the Forged Cemented Stem is supplied sterile, so it is recommended to follow proper sterilization procedures before use.

  • What is the regulatory status of the Forged Cemented Stem?

    The Forged Cemented Stem has FDA 510K clearance, indicating that it has been found to be substantially equivalent to a predicate device.