Cleared Traditional

HyperSuture All Blue Extension Line (K241376) - FDA 510(k) Clearance

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

K241376 · Threadstone, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
86d
Days
Class 2
Risk

K241376 is an FDA 510(k) clearance for the HyperSuture All Blue Extension Line. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Threadstone, LLC (Millersville, US). The FDA issued a Cleared decision on August 9, 2024 after a review of 86 days - a notably fast clearance cycle.

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: 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 Threadstone, LLC devices

Submission Details

510(k) Number K241376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2024
Decision Date August 09, 2024
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 73
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K241376.
PowerKnot High Strength Sutures
K252225 · Medacta International S.A. · Sep 2025
HS Fiber
K252201 · Riverpoint Medical · Aug 2025
HyperSuture White/Green Extension Line
K242201 · Threadstone, LLC · Mar 2025
HyperSuture Extension Line
K234079 · Threadstone, LLC · May 2024
HS Fiber Sutures
K231163 · Riverpoint Medical · Jan 2024
HyperSuture
K230311 · Threadstone, LLC · Nov 2023