Cleared Traditional

ACS? LD FB Knee System

K234044 · Implantcast GmbH · Orthopedic

Sep 2024

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K234044 is an FDA 510(k) clearance for the ACS? LD FB Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on September 6, 2024, 260 days after receiving the submission on December 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K234044 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2023
Decision Date	September 06, 2024
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560