Cleared Traditional

K981850 - SILIMED CHIN IMPLANTS

K981850 is an FDA 510(k) clearance for SILIMED CHIN IMPLANTS, manufactured by Silimed, LLC. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K981850 · Silimed, LLC · General & Plastic Surgery device
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Jul 1998
Decision
44d
Days
Class 2
Risk

K981850 is an FDA 510(k) clearance for the SILIMED CHIN IMPLANTS. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Silimed, LLC (Crofton, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 44 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 Silimed, LLC devices

FDA 510(k) Submission Details - K981850

510(k) Number K981850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1998
Decision Date July 09, 1998
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 K981850.
PILLAR CHIN IMPLANT
K992239 · Pillar Surgical, Inc. · Nov 1999
STANDARD CHIN
K983754 · Surgical Technology Laboratories, Inc. · Nov 1998
SEARE BIOMEDICAL CHIN IMPLANTS
K982752 · Seare Biomedical Corp. · Sep 1998
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K980444 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K980445 · Spectrum Designs, Inc. · May 1998
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446 · Spectrum Designs, Inc. · May 1998