Cleared Special

K012507 - THE TRABECULAR METAL TECHNOLOGY ACETABU...

K012507 is the FDA 510(k) clearance for THE TRABECULAR METAL TECHNOLOGY ACETABU... by Implex Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 24-day FDA review.

K012507 · Implex Corp. · Orthopedic device
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Aug 2001
Decision
24d
Days
Class 2
Risk

K012507 is an FDA 510(k) clearance for the THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY .... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Implex Corp. devices

Submission Details

510(k) Number K012507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date August 30, 2001
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 428
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K012507.
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · Smith & Nephew, Inc. · Dec 2001
CONVERGE ACETABULAR SYSTEM
K012739 · Sulzer Orthopedics, Inc. · Nov 2001
AML HIP PROSTHESIS
K012364 · DePuy Orthopaedics, Inc. · Oct 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · DePuy Orthopaedics, Inc. · Jul 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · Exactech, Inc. · Apr 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · Howmedica Osteonics Corp. · Apr 2001