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Kinematic II Knee System

by Howmedica Corp.

510(k) K823420

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 NumberK823420 Date7 Feb 1983ClearedStatusActive

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  • Withdrawn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
KRO
Device Class
Class II
Regulation
21 CFR Part 888.3510
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 Kinematic II Knee System is a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, designed to replace the knee joint in orthopedic procedures. It provides constrained articulation and structural support for patients requiring limb salvage or total knee arthroplasty, ensuring stability and mobility restoration through its metal and polymer components.

This device is intended for cemented fixation and is used in surgical settings by orthopedic surgeons. Supplied as a reusable system, it requires sterile preparation for implantation. The system is classified under FDA regulation 888.3510 and holds a Traditional 510(k) clearance (K823420) for substantial equivalence in orthopedic applications. Multiple FEI numbers (e.g., 3004748528, 1020279) reference its regulatory registration.

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