Cleared Traditional

K140674 - EXACTECH TAPERED WEDGE FEMORAL STEM

K140674 is an FDA 510(k) clearance for EXACTECH TAPERED WEDGE FEMORAL STEM, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K140674 · Exactech, Inc. · Orthopedic device
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Jun 2014
Decision
104d
Days
Class 2
Risk

K140674 is an FDA 510(k) clearance for the EXACTECH TAPERED WEDGE 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 June 30, 2014 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Exactech, Inc. devices

FDA 510(k) Submission Details - K140674

510(k) Number K140674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date June 30, 2014
Days to Decision 104 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 509
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K140674.
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · Biomet, Inc. · Aug 2014
MINIMA S SYSTEM
K141327 · Lima Corporate S.P.A. · Aug 2014
EXCIA TOTAL HIP SYSTEM
K140915 · Aesculap Implant Systems, LLC · Jul 2014
MASTERSL FEMORAL STEM
K140975 · Lima Corporate S.P.A. · Jun 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K140676 · Microport Orthopedics, Inc. · May 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
K140043 · Microport Orthopedics, Inc. · Apr 2014