Skip to content

Perfecta Total Hip System, Hemi-Head Component

by Orthomet, Inc.

510(k) K915868

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 NumberK915868 Date23 Mar 1992ClearedStatusActive

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  • Withdrawn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
KWL
Device Class
Class II
Regulation
21 CFR Part 888.3360
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 Perfecta Total Hip System, Hemi-Head Component is a prosthesis, hip, hemi-, femoral, metal device. It is classified as a Class II device with special controls. The device is designed to replace the hip joint, with the hemi-head component being a part of the overall system.

The Perfecta Total Hip System, Hemi-Head Component is supplied by Orthomet, Inc. and has been cleared by the FDA with a 510(k) clearance, K915868. The device has a product code of KWL and is regulated under regulation number 888.3360. It is intended for orthopedic use.

Other devices from Orthomet, Inc.

See all devices from Orthomet, 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 Perfecta Total Hip System, Hemi-Head Component used for?

    The Perfecta Total Hip System, Hemi-Head Component is used to replace the hip joint, specifically designed for orthopedic use.

  • Is the Perfecta Total Hip System, Hemi-Head Component supplied sterile?

    The device data does not specify if the component is supplied sterile, it's recommended to check the packaging or manufacturer's instructions for this information.

  • What is the regulatory classification of the Perfecta Total Hip System, Hemi-Head Component?

    The device is classified as a Class II device with special controls, regulated under regulation number 888.3360.