Cleared Traditional

K961210 - SAM FACIAL IMPLANT

K961210 is the FDA 510(k) clearance for SAM FACIAL IMPLANT by W.L. Gore & Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code LZK) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K961210 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
83d
Days
Class 2
Risk

K961210 is an FDA 510(k) clearance for the SAM FACIAL IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 19, 1996 after a review of 83 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K961210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date June 19, 1996
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K961210.
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
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · Implantech Associates, Inc. · Jan 1995
FLOWERS MEDIAL MALAR IMPLANT
K921582 · Implantech Associates, Inc. · May 1992
TRAPEZOIDAL MALAR IMPLANT
K911513 · Implantech Associates, Inc. · Jul 1991