Cleared Traditional

K961071 - THE MAGNUM CHIN IMPLANT

K961071 is an FDA 510(k) clearance for THE MAGNUM CHIN IMPLANT, manufactured by Rand Scientific Corp.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K961071 · Rand Scientific Corp. · General & Plastic Surgery device
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Apr 1996
Decision
32d
Days
Class 2
Risk

K961071 is an FDA 510(k) clearance for the THE MAGNUM CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 32 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 Rand Scientific Corp. devices

FDA 510(k) Submission Details - K961071

510(k) Number K961071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date April 19, 1996
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWP Device Classification - Class 2, Special Controls

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

All 48
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K961071.
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DURALASTIC ANATOMICAL CHIN IMPLANTS
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DURALASTIC ANATOMICAL CHIN IMPLANTS
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PERMARIDGE HYDROXYLAPATITE MATRIX
K960349 · Ceramed Corp. · Mar 1996
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K952677 · Porex Surgical, Inc. · Aug 1995
GORE-TEX SAM FACIAL IMPLANT
K946267 · W.L. Gore & Associates, Inc. · Mar 1995