Cleared Traditional

K223122 - MENIX® (FDA 510(k) Clearance)

Also includes:
MENIX® DUO

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223122 · S.B.M. Sas (Science & Bio Materials) · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
304d
Days
Class 2
Risk

K223122 is an FDA 510(k) clearance for the MENIX®. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by S.B.M. Sas (Science & Bio Materials) (Lourdes, FR). The FDA issued a Cleared decision on August 3, 2023 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all S.B.M. Sas (Science & Bio Materials) devices

Submission Details

510(k) Number K223122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date August 03, 2023
Days to Decision 304 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
190d slower than avg
Panel avg: 114d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 172
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K223122.
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