Cleared Traditional

K003504 - RT-PLUS MODULAR CEMENTED KNEE COMPONENTS

K003504 is an FDA 510(k) clearance for RT-PLUS MODULAR CEMENTED KNEE COMPONENTS, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K003504 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K003504

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
Combination Product No
PCCP Authorized No
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.

KRO Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K003504.
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K010774 · Biomet, Inc. · Apr 2001
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K002552 · Howmedica Osteonics Corp. · Nov 2000
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K001957 · Howmedica Osteonics Corp. · Jul 2000