Cleared Traditional

CHIN IMPLANT STYLE I (K945998) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945998 · King & Spalding · General & Plastic Surgery device
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Feb 1995
Decision
69d
Days
Class 2
Risk

K945998 is an FDA 510(k) clearance for the CHIN IMPLANT STYLE I. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by King & Spalding (Washington, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - 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 King & Spalding devices

Submission Details

510(k) Number K945998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1994
Decision Date February 07, 1995
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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.

Regulatory Peers - FWP Prosthesis, Chin, Internal

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