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Align 360 Medialized Patella Component

by Cardo Medical, Inc.

510(k) K092803

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 NumberK092803 Date23 Dec 2009ClearedStatusActive

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  • Withdrawn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)

Full name
Cardo Medical Align 360 Medialized Patella Component
510(k) Number
FDA Product Code
JWH
FDA applicant
Cardo Medical Corp.
Device Class
Class II
Regulation
21 CFR Part 888.3560
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 Align 360 Medialized Patella Component is a cemented orthopedic implant classified as a Patella Resurfacing Device (FDA Product Code JWH). It is designed to resurface the patella during patellofemoral arthroplasty or total knee replacement procedures, providing a medialized dome geometry to improve patellofemoral tracking and joint function.

This device is supplied sterile and intended for single-use in orthopedic surgery. It is regulated under the FDA’s 510(k) Premarket Notification process (K092803) and is classified as substantially equivalent to predicate devices. The component is intended for cemented fixation and must be used in accordance with standard surgical techniques for patella resurfacing.

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