Cleared Special

LinkSymphoKnee ? Fixed Bearing Ultracongruent (FB UC) Articulating Surface

K230471 · Waldemar Link GmbH & Co. KG · Orthopedic

Mar 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K230471 is an FDA 510(k) clearance for the LinkSymphoKnee ? Fixed Bearing Ultracongruent (FB UC) Articulating Surface, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Waldemar Link GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on March 21, 2023, 28 days after receiving the submission on February 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K230471 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2023
Decision Date	March 21, 2023
Days to Decision	28 days
Submission Type	Special
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