Cleared Traditional

K980138 - SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT

K980138 is an FDA 510(k) clearance for SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT, manufactured by Spectrum Designs, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K980138 · Spectrum Designs, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
78d
Days
Class 2
Risk

K980138 is an FDA 510(k) clearance for the SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 78 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 Spectrum Designs, Inc. devices

FDA 510(k) Submission Details - K980138

510(k) Number K980138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1998
Decision Date April 03, 1998
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 38
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K980138.
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
K980462 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K980463 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K980461 · Spectrum Designs, Inc. · Mar 1998
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
K952677 · Porex Surgical, Inc. · Aug 1995
GORE-TEX SAM FACIAL IMPLANT
K946267 · W.L. Gore & Associates, Inc. · Mar 1995