Cleared Traditional

Engage? Partial Knee System

K190439 · Engage Uni, LLC · Orthopedic
Nov 2019
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K190439 is an FDA 510(k) clearance for the Engage? Partial Knee System, a Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (Class II — Special Controls, product code NJD), submitted by Engage Uni, LLC (Winter Park, US). The FDA issued a Cleared decision on November 21, 2019, 269 days after receiving the submission on February 25, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3535.

Submission Details

510(k) Number K190439 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2019
Decision Date November 21, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3535
Definition Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery.