Cleared Traditional

K052504 - GLUTEAL IMPLANT

K052504 is the FDA 510(k) clearance for GLUTEAL IMPLANT by Implantech Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code MIB) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K052504 · Implantech Associates, Inc. · General & Plastic Surgery device
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Nov 2005
Decision
52d
Days
Class 2
Risk

K052504 is an FDA 510(k) clearance for the GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - the FDA general and plastic surgery 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 Implantech Associates, Inc. devices

Submission Details

510(k) Number K052504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2005
Decision Date November 04, 2005
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIB Elastomer, Silicone Block
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 General & Plastic Surgery devices follow this clearance model.