Cleared Traditional

K040630 - TRABECULAR METAL FEMORAL CONE AUGMENTS

K040630 is the FDA 510(k) clearance for TRABECULAR METAL FEMORAL CONE AUGMENTS by Implex Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K040630 · Implex Corp. · Orthopedic device
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Sep 2004
Decision
204d
Days
Class 2
Risk

K040630 is an FDA 510(k) clearance for the TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 204 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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

Submission Details

510(k) Number K040630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date September 30, 2004
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 762
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K040630.
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