Cleared Traditional

K101994 - APEX KNEE MODULAR TIBIA SYSTEM

K101994 is an FDA 510(k) clearance for APEX KNEE MODULAR TIBIA SYSTEM, manufactured by Omnlife Science. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K101994 · Omnlife Science · Orthopedic device
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Sep 2010
Decision
75d
Days
Class 2
Risk

K101994 is an FDA 510(k) clearance for the APEX KNEE MODULAR TIBIA SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Omnlife Science (East Taunton, US). The FDA issued a Cleared decision on September 28, 2010 after a review of 75 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 Omnlife Science devices

FDA 510(k) Submission Details - K101994

510(k) Number K101994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2010
Decision Date September 28, 2010
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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

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