Cleared Traditional

K981835 - SILIMED MALAR IMPLANT

K981835 is an FDA 510(k) clearance for SILIMED MALAR IMPLANT, manufactured by Silimed, LLC. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K981835 · Silimed, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
44d
Days
Class 2
Risk

K981835 is an FDA 510(k) clearance for the SILIMED MALAR IMPLANT. Classified as Implant, Malar (product code LZK), 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 - K981835

510(k) Number K981835 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
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.

LZK Device Classification - Class 2, Special Controls

Product Code LZK Implant, Malar
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 - LZK Implant, Malar

All 16
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K981835.
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · Implantech Associates, Inc. · Nov 2000
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · Implantech Associates, Inc. · Nov 1997
BONE SOURCE HYDROXYAPATITE
K970400 · Orthofix, Inc. · May 1997
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · Implantech Associates, Inc. · Aug 1996
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511 · Lifecore Biomedical, Inc. · Jun 1996
SAM FACIAL IMPLANT
K961210 · W.L. Gore & Associates, Inc. · Jun 1996