Cleared Traditional

K103837 - BALANCED KNEE SYSTEM REVISION OFFSET TIBIA

K103837 is an FDA 510(k) clearance for BALANCED KNEE SYSTEM REVISION OFFSET TIBIA, manufactured by Ortho Development. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K103837 · Ortho Development · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2011
Decision
84d
Days
Class 2
Risk

K103837 is an FDA 510(k) clearance for the BALANCED KNEE SYSTEM REVISION OFFSET TIBIA. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Ortho Development (Draper, US). The FDA issued a Cleared decision on March 24, 2011 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Development devices

FDA 510(k) Submission Details - K103837

510(k) Number K103837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date March 24, 2011
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 842
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K103837.
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VANGUARD ASYMMETRICAL PATELLAR COMPONENT
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