Cleared Traditional

K910458 - ZARA SOFT TIP CHIN IMPLANT

K910458 is an FDA 510(k) clearance for ZARA SOFT TIP CHIN IMPLANT, manufactured by Byron Medical. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K910458 · Byron Medical · General & Plastic Surgery device
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Feb 1991
Decision
15d
Days
Class 2
Risk

K910458 is an FDA 510(k) clearance for the ZARA SOFT TIP CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on February 19, 1991 after a review of 15 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 Byron Medical devices

FDA 510(k) Submission Details - K910458

510(k) Number K910458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date February 19, 1991
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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 27
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K910458.
HIGH PROFILE CHIN IMPLANT
K911516 · Implantech Associates, Inc. · Jul 1991
ZARA CHIN IMPLANT
K910456 · Byron Medical · Feb 1991
ZARA EXTENDED CHIN IMPLANT
K910457 · Byron Medical · Feb 1991
FLOWERS CHIN IMPLANT
K905267 · Implantech Associates, Inc. · Jan 1991
FLOWERS JOWL IMPLANT
K905268 · Implantech Associates, Inc. · Jan 1991
CURVILINEAR SILICONE CHIN IMPLANT
K902941 · Implantech Associates, Inc. · Aug 1990