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Vitalite E Cross-Linked Polyethylene Acetabular Insert

by Consensus Orthopedics, Inc.

510(k) K130652

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 NumberK130652 Date17 Dec 2013ClearedStatusActive

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  • Withdrawn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
OQG
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Vitalite E Cross-Linked Polyethylene Acetabular Insert is a Hip Prosthesis, Semi-Constrained, designed for use in total hip arthroplasty. It features a cross-linked polyethylene component intended to provide durable articulation with a metallic femoral head, offering enhanced wear resistance and stability in cemented or uncemented applications.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as Class II under FDA regulations and adheres to special controls for hip prostheses. Available in multiple sizes and configurations (as referenced by FEI numbers), it requires proper handling and storage to maintain sterility and structural integrity prior to implantation.

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