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Dimension Total Hip Prosthesis Porous Coated

by Kirschner Medical Corp.

510(k) K854107

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 NumberK854107 Date10 Mar 1986DecidedStatusActive

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  • Withdrawn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
JDL
Device Class
Class III
Regulation
21 CFR Part 888.3320
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 18 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 Dimension Total Hip Prosthesis Porous Coated is a semi-constrained metal cemented acetabular component for total hip replacement. This device is designed to replace the damaged or diseased acetabulum, providing stability and restoring hip joint function through a porous-coated surface that promotes osseointegration with the surrounding bone.

This prosthesis is intended for use in orthopedic surgical settings and is supplied as a reusable medical device. It is classified as a Class III device under FDA regulations and holds a Traditional 510(k) clearance, with decision documentation dated March 10, 1986. Multiple registration numbers and FEI numbers are associated with its variants, reflecting its regulatory compliance and distribution for hip arthroplasty procedures.

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