Cleared Traditional

K000666 - TC-PLUS SOLUTION KNEE

K000666 is an FDA 510(k) clearance for TC-PLUS SOLUTION KNEE, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K000666 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
228d
Days
Class 2
Risk

K000666 is an FDA 510(k) clearance for the TC-PLUS SOLUTION KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on October 13, 2000 after a review of 228 days - an extended review cycle.

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: 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K000666

510(k) Number K000666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date October 13, 2000
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K000666.
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740 · Smith & Nephew, Inc. · Nov 2000
BIOMET SCK KNEE SYSTEM
K003296 · Biomet, Inc. · Nov 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335 · Sulzer Orthopedics, Inc. · Oct 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · Biomet, Inc. · Oct 2000
ASCENT KNEE SYSTEM
K002678 · Biomet, Inc. · Sep 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · Biomet, Inc. · Sep 2000