Cleared Special

K013340 - RT-PLUS KNEE ADDITIONAL COMPONENTS

K013340 is an FDA 510(k) clearance for RT-PLUS KNEE ADDITIONAL COMPONENTS, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code KRO cleared through the Special 510(k) pathway after a 72-day FDA review.

K013340 · Plus Orthopedics · Orthopedic device
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Dec 2001
Decision
72d
Days
Class 2
Risk

K013340 is an FDA 510(k) clearance for the RT-PLUS KNEE ADDITIONAL 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 December 20, 2001 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Plus Orthopedics devices

FDA 510(k) Submission Details - K013340

510(k) Number K013340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date December 20, 2001
Days to Decision 72 days
Submission Type Special
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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 K013340.
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · Biomet, Inc. · Jun 2002
EXPANDABLE KNEE
K020381 · Biomet Orthopedics, Inc. · May 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · Zimmer, Inc. · Jan 2002
MOST OPTIONS SYSTEM
K013031 · Sulzer Orthopedics, Inc. · Dec 2001
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · Wrightmedicaltechnologyinc · Dec 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · Depuy, Inc. · Sep 2001