Cleared Special

K032215 - VKS/TC-PLUS REVISION KNEE

K032215 is an FDA 510(k) clearance for VKS/TC-PLUS REVISION KNEE, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 18-day FDA review.

K032215 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
18d
Days
Class 2
Risk

K032215 is an FDA 510(k) clearance for the VKS/TC-PLUS REVISION KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Plus Orthopedics (Round Rock, US). The FDA issued a Cleared decision on August 8, 2003 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 - K032215

510(k) Number K032215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date August 08, 2003
Days to Decision 18 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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 K032215.
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729 · Howmedica Osteonics Corp. · Sep 2003
COLUMBUS (PS)
K030367 · Aesculap, Inc. · Aug 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · Smith & Nephew, Inc. · Aug 2003
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
K031201 · Ortho Development Corp. · Jul 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · Exactech, Inc. · Apr 2003
PROVEN MODULAR TIBIAL TRAY
K030577 · Stelkast Company · Mar 2003