Cleared Traditional

SILMAX CONTOUR CARVING BLOCK IMPLANT (K002629) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002629 · Pillar Surgical, Inc. · Ear, Nose, Throat device
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Nov 2000
Decision
89d
Days
Class 2
Risk

K002629 is an FDA 510(k) clearance for the SILMAX CONTOUR CARVING BLOCK IMPLANT. Classified as Polymer, Ent Synthetic, Porous Polyethylene (product code JOF), Class II - Special Controls.

Submitted by Pillar Surgical, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 20, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pillar Surgical, Inc. devices

Submission Details

510(k) Number K002629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date November 20, 2000
Days to Decision 89 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 89d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOF Polymer, Ent Synthetic, Porous Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 Ear, Nose, Throat devices follow this clearance model.