Cleared Traditional

ACS LD Uni FB Knee System

K203341 · Implantcast GmbH · Orthopedic

Jan 2021

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K203341 is an FDA 510(k) clearance for the ACS LD Uni FB Knee System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on January 8, 2021, 57 days after receiving the submission on November 12, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K203341 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2020
Decision Date	January 08, 2021
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520