Cleared Special

NOVATION 12/14 PRESS-FIT FEMORAL STEM (K042842) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042842 · Exactech, Inc. · Orthopedic device
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Nov 2004
Decision
26d
Days
Class 2
Risk

K042842 is an FDA 510(k) clearance for the NOVATION 12/14 PRESS-FIT FEMORAL STEM. 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 November 9, 2004 after a review of 26 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 K042842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2004
Decision Date November 09, 2004
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K042842.
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
K041940 · Howmedica Osteonics Corp. · Feb 2005
CORAIL AMT HIP PROSTHESIS
K042992 · DePuy Orthopaedics, Inc. · Feb 2005
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · Howmedica Osteonics Corp. · Nov 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · Howmedica Osteonics Corp. · Aug 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803 · Zimmer, Inc. · Apr 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · DePuy Orthopaedics, Inc. · Apr 2004