Cleared Traditional

K971478 - DURALASTIC ANATOMICAL CHIN IMPLANTS

K971478 is an FDA 510(k) clearance for DURALASTIC ANATOMICAL CHIN IMPLANTS, manufactured by Allied Biomedical Corp.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K971478 · Allied Biomedical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
86d
Days
Class 2
Risk

K971478 is an FDA 510(k) clearance for the DURALASTIC ANATOMICAL CHIN IMPLANTS. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Allied Biomedical Corp. (Paso Robles, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 86 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 Allied Biomedical Corp. devices

FDA 510(k) Submission Details - K971478

510(k) Number K971478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1997
Decision Date July 18, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 44
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K971478.
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K980138 · Spectrum Designs, Inc. · Apr 1998
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K980461 · Spectrum Designs, Inc. · Mar 1998
DURALASTIC ANATOMICAL CHIN IMPLANTS
K973575 · Hanson Medical, Inc. · Nov 1997
PERMARIDGE HYDROXYLAPATITE MATRIX
K960349 · Ceramed Corp. · Mar 1996
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
K952677 · Porex Surgical, Inc. · Aug 1995
GORE-TEX SAM FACIAL IMPLANT
K946267 · W.L. Gore & Associates, Inc. · Mar 1995