Cleared Special

K003181 - IMPLEX CONTINUUM HIP SYSTEM ACETABULAR ...

K003181 is the FDA 510(k) clearance for IMPLEX CONTINUUM HIP SYSTEM ACETABULAR ... by Implex Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K003181 · Implex Corp. · Orthopedic device
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Nov 2000
Decision
27d
Days
Class 2
Risk

K003181 is an FDA 510(k) clearance for the IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ. 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 November 7, 2000 after a review of 27 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 K003181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2000
Decision Date November 07, 2000
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 424
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K003181.
PROTRACT PRESS FIT HIP STEM
K003447 · Stelkast Company · Dec 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960 · Zimmer, Inc. · Dec 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429 · Biomet, Inc. · Nov 2000
LINEAGE ACETABULAR SYSTEM
K002149 · Wrightmedicaltechnologyinc · Aug 2000
TITAN POROCOAT HIP PROSTHESIS
K001991 · DePuy Orthopaedics, Inc. · Aug 2000
TRI-LOCK HIP STEM
K001982 · DePuy Orthopaedics, Inc. · Jul 2000