Cleared Special

K090764 - NOVATION CFS PRESS-FIT AND CEMENTED STEMS

K090764 is an FDA 510(k) clearance for NOVATION CFS PRESS-FIT AND CEMENTED STEMS, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Special 510(k) pathway after a 29-day FDA review.

K090764 · Exactech, Inc. · Orthopedic device
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Apr 2009
Decision
29d
Days
Class 2
Risk

K090764 is an FDA 510(k) clearance for the NOVATION CFS PRESS-FIT AND CEMENTED STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on April 21, 2009 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K090764

510(k) Number K090764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date April 21, 2009
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 73
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K090764.
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