Cleared Traditional

SIGMA High Performance (HP) Partial Knee System (K193549) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193549 · Depuy Ireland UC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2020
Decision
118d
Days
Class 2
Risk

K193549 is an FDA 510(k) clearance for the SIGMA High Performance (HP) Partial Knee System. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on April 16, 2020 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy Ireland UC devices

Submission Details

510(k) Number K193549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Depuy Synthes, Inc.
Brad Osborne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 90
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K193549.
NanoOrtho NanoKnee® System
K190633 · Nanoortho, LLC · Dec 2019
EVOLUTION UNICONDYLAR KNEE SYSTEM
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STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567 · Howmedica Osteonics Corp. · Oct 2008
TRIATHLON PKR SYSTEM
K071881 · Howmedica Osteonics Corp. · Oct 2007
DEPUY GCK TIBIAL COMPONENTS
K070267 · DePuy Orthopaedics, Inc. · Aug 2007
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004