Cleared Traditional

SIGMA High Performance (HP) Partial Knee System

K193549 · Depuy Ireland UC · Orthopedic

Apr 2020

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K193549 is an FDA 510(k) clearance for the SIGMA High Performance (HP) Partial Knee System, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on April 16, 2020, 118 days after receiving the submission on December 20, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K193549 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2019
Decision Date	April 16, 2020
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530