Cleared Special

EXACTECH NOVATION CROWN CUP AND LINERS (K070479) - FDA 510(k) Clearance

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

K070479 · Exactech, Inc. · Orthopedic device
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Mar 2007
Decision
23d
Days
Class 2
Risk

K070479 is an FDA 510(k) clearance for the EXACTECH NOVATION CROWN CUP AND LINERS. 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 March 15, 2007 after a review of 23 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 K070479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date March 15, 2007
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 K070479.
STRYKER MODULAR HIP SYSTEM
K071082 · Howmedica Osteonics Corp. · Sep 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554 · DePuy Orthopaedics, Inc. · Sep 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885 · Howmedica Osteonics Corp. · May 2007
TRIDENT II ACETABULAR SYSTEM
K063616 · Howmedica Osteonics Corp. · Dec 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748 · DePuy Orthopaedics, Inc. · Nov 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · Exactech, Inc. · Nov 2006