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H.N. Metal Backed Acetabular Cup, Noncemented

by Med-Tek Corp.

510(k) K901626

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 NumberK901626 Date14 Aug 1990ClearedStatusActive

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  • Withdrawn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
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), as classified by the FDA. It is a metal-backed acetabular cup designed for uncemented fixation in total hip arthroplasty, providing structural support to the acetabulum while promoting osseointegration with the surrounding bone. The semi-constrained design limits translation and rotation through geometric articulation surfaces without a cross-joint linkage, enhancing stability in hip replacement procedures.

The H.N. Metal-Backed Acetabular Cup, Noncemented is intended for surgical implantation by orthopedic specialists in a sterile operating environment. Supplied as a single-use, reusable device (as per regulatory submission), it requires proper sterilization and handling per manufacturer instructions. The device is classified as Class III under FDA regulations and holds an FDA 510(k) clearance (K901626) for substantial equivalence to a predicate device. Multiple registration numbers (e.g., 8043792) reflect its global regulatory filings, though no additional specifications on MRI safety or storage conditions are provided in the data.

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