Cleared Traditional

K192953 - APTOS Threads – Polypropylene Surgical ...

K192953 is the FDA 510(k) clearance for APTOS Threads – Polypropylene Surgical ... by Aptos, LLC. It is a Class 2 General & Plastic Surgery device (product code GAW) cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K192953 · Aptos, LLC · General & Plastic Surgery device
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Aug 2020
Decision
311d
Days
Class 2
Risk

K192953 is an FDA 510(k) clearance for the APTOS Threads – Polypropylene Surgical Sutures. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Aptos, LLC (Tbilisi, GE). The FDA issued a Cleared decision on August 27, 2020 after a review of 311 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 878.5010 - 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.

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Submission Details

510(k) Number K192953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2019
Decision Date August 27, 2020
Days to Decision 311 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
196d slower than avg
Panel avg: 115d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 25
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K192953.
Non absorbable Surgical Polypropylene Suture
K230746 · Shandong Haidike Medical Products Co., Ltd. · Sep 2023
Vesseal
K221280 · Lydus Medical , Ltd. · Dec 2022
DURAMESH Mesh Suture
K211178 · Msi · Sep 2022
Deklene MAXX
K193530 · Teleflex Medical · Mar 2020
Silhouette Featherlift / Silhouette Lift
K191299 · Silhouette Lift, Inc. · Jun 2019
REXLENE
K173747 · Sm Eng Co., Ltd. · Dec 2018