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Domed and Finned Acetabular Component

by Orthomet, Inc.

510(k) K901328

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 NumberK901328 Date22 May 1990DecidedStatusActive

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  • Withdrawn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
SN

Overview

AI-generated summary, 1 Oct 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 domed and finned acetabular component for hip arthroplasty, classified under product code JDI as a substantially equivalent orthopedic implant. It is designed to replace the damaged or diseased acetabulum, providing a stable bearing surface for articulation with a femoral component. The dome shape and finned design enhance stability and fixation within the pelvic bone, contributing to long-term implant integration.

The Domed and Finned Acetabular Component is intended for surgical use in orthopedic procedures under sterile conditions. It is supplied as a single-use implant, requiring proper handling and sterilization by the manufacturer before packaging. The device is regulated under FDA 510(k) clearance (K901328) and falls under the Orthopedic advisory committee classification, with clearance granted in 1990. No additional regulatory status beyond the stated clearance is implied.

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Questions

AI-generated answers, 1 Oct 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 Domed and Finned Acetabular Component used for?

    This device is designed specifically for hip arthroplasty to replace a damaged or diseased acetabulum. Its dome shape and finned design improve stability and fixation within the pelvic bone, helping to ensure long-term integration with the femoral component for smoother articulation.

  • How is the Domed and Finnned Acetabular Component supplied?

    The device is supplied as a single-use implant. It is sterilized by the manufacturer before packaging, ensuring it is ready for sterile surgical use. Proper handling is required to maintain its sterile condition.

  • Is the Domed and Finnned Acetabular Component reusable?

    No, this device is intended for single-use only. Its design and sterilization process are optimized for one-time surgical application to ensure patient safety and implant integrity.

  • What regulatory clearance does the Domed and Finnned Acetabular Component hold?

    The device holds FDA 510(k) clearance under the classification of substantially equivalent orthopedic implants (product code JDI). It was reviewed by the Orthopedic Advisory Committee in 1990 and granted clearance under the traditional review pathway.

  • How does the finned design contribute to its function?

    The finned design enhances the acetabular component’s fixation within the pelvic bone, providing additional surface area for osseointegration. This improves stability and reduces the risk of loosening over time, supporting long-term implant performance.