Cleared Traditional

RT-PLUS MODULAR CEMENTED KNEE COMPONENTS (K003504) - FDA 510(k) Clearance

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

K003504 · Plus Orthopedics · Orthopedic device
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May 2001
Decision
179d
Days
Class 2
Risk

K003504 is an FDA 510(k) clearance for the RT-PLUS MODULAR CEMENTED KNEE COMPONENTS. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on May 11, 2001 after a review of 179 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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

Submission Details

510(k) Number K003504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date May 11, 2001
Days to Decision 179 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 122d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 53
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K003504.
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · Zimmer, Inc. · Jan 2002
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · Wrightmedicaltechnologyinc · Dec 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · Depuy, Inc. · Sep 2001
AVL HINGE KNEE SYSTEM
K010774 · Biomet, Inc. · Apr 2001
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · Howmedica Osteonics Corp. · Nov 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · Howmedica Osteonics Corp. · Jul 2000