Cleared Traditional

K031201 - ORTHO DEVELOPMENT BALANCED KNEE MODULAR...

K031201 is an FDA 510(k) clearance for ORTHO DEVELOPMENT BALANCED KNEE MODULAR..., manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031201 · Ortho Development Corp. · Orthopedic device
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Jul 2003
Decision
90d
Days
Class 2
Risk

K031201 is an FDA 510(k) clearance for the ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on July 15, 2003 after a review of 90 days - within the typical 510(k) review window.

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 Ortho Development Corp. devices

FDA 510(k) Submission Details - K031201

510(k) Number K031201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2003
Decision Date July 15, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K031201.
COLUMBUS (PS)
K030367 · Aesculap, Inc. · Aug 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · Smith & Nephew, Inc. · Aug 2003
VKS/TC-PLUS REVISION KNEE
K032215 · Plus Orthopedics · Aug 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · Exactech, Inc. · Apr 2003
PROVEN MODULAR TIBIAL TRAY
K030577 · Stelkast Company · Mar 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · Smith & Nephew, Inc. · Feb 2003