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Vitality Hip Stem

by Encore Orthopedics, Inc.

510(k) K962560

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 NumberK962560 Date19 Sep 1996ClearedStatusActive

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  • Withdrawn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, 24 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 Vitality Hip Stem is a sterile implantable femoral component of a total hip prosthesis. It is designed to replace the femoral head and neck and is intended for use in patients who are candidates for total or hemi-hip arthroplasty.

The device is composed of two or more separate pieces, such as a head, neck, and stem, which are designed to be joined. It features a coating, such as porous materials or hydroxyapatite, intended to improve fixation. This device received FDA 510(k) clearance under K962560.

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