Cleared Traditional

PFC SIGMA Knee System (K182301) - FDA 510(k) Clearance

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

K182301 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
441d
Days
Class 2
Risk

K182301 is an FDA 510(k) clearance for the PFC SIGMA Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K182301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2018
Decision Date November 08, 2019
Days to Decision 441 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
319d slower than avg
Panel avg: 122d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 523
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K182301.
LOSPA II Knee System
K192507 · Corentec Co., Ltd. · Dec 2019
World Knee Total Knee Systems
K190577 · Signature Orthopaedics Pty, Ltd. · Nov 2019
Physica KR Liner and SMR Reverse Humeral Liner
K190911 · Limacorporate · Nov 2019
Madison Total Knee System
K192084 · Implanet, S.A. · Oct 2019
OMNI TiN Coated Apex Knee™ System
K191765 · Omni Life Science, Inc. · Sep 2019
Persona Revision Knee System
K191625 · Zimmer, Inc. · Sep 2019