Cleared Special

K083392 - NOVATION 12/14 CEMENTED FEMORAL STEMS

K083392 is the FDA 510(k) clearance for NOVATION 12/14 CEMENTED FEMORAL STEMS by Exactech, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K083392 · Exactech, Inc. · Orthopedic device
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Dec 2008
Decision
30d
Days
Class 2
Risk

K083392 is an FDA 510(k) clearance for the NOVATION 12/14 CEMENTED FEMORAL STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 17, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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

Submission Details

510(k) Number K083392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date December 17, 2008
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K083392.
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K081860 · Zimmer, Inc. · Sep 2008