Cleared Traditional

K031462 - THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS

K031462 is an FDA 510(k) clearance for THE NEXGEN KNEE SYSTEM UNCEMENTED COMPO..., manufactured by Implex Corp.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031462 · Implex Corp. · Orthopedic device
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Aug 2003
Decision
90d
Days
Class 2
Risk

K031462 is an FDA 510(k) clearance for the THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on August 6, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Implex Corp. devices

FDA 510(k) Submission Details - K031462

510(k) Number K031462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2003
Decision Date August 06, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 141
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K031462.
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · Zimmer, Inc. · Oct 2003
DURACON TOTAL KNEE SYSTEM
K032163 · Howmedica Osteonics Corp. · Sep 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · Howmedica Osteonics Corp. · Sep 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · Smith & Nephew, Inc. · May 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · Smith & Nephew, Inc. · May 2003