SIGMA High Performance (HP) Partial Knee System

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Sigma High Performance (hp) Partial Knee System.

Pre-market Notification Details

• Device ID: K193549
• 510k Number: K193549
• Device Name: SIGMA High Performance (HP) Partial Knee System
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: DePuy Ireland UC Loughbeg Ringaskiddy, IE
• Contact: Erin Combs
• Correspondent: Brad Osborne; DePuy Synthes, Inc. 700 Orthopaedic Drive Warsaw, IN 46582
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-20
• Decision Date: 2020-04-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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