Cleared Traditional

K250095 - All-Suture Dual Anchor System

K250095 is an FDA 510(k) clearance for All-Suture Dual Anchor System, manufactured by Suturetech, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K250095 · Suturetech, Inc. · Orthopedic device
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Sep 2025
Decision
234d
Days
Class 2
Risk

K250095 is an FDA 510(k) clearance for the All-Suture Dual Anchor System. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Suturetech, Inc. (Durham, US). The FDA issued a Cleared decision on September 5, 2025 after a review of 234 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Suturetech, Inc. devices

FDA 510(k) Submission Details - K250095

510(k) Number K250095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2025
Decision Date September 05, 2025
Days to Decision 234 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 122d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 438
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K250095.
Arthrex SutureTak Suture Anchor
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Aevumed FASE Suture Anchor
K253040 · Aevumed, Inc. · Oct 2025
Mini Superhawk Suture Anchor System
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Aevumed PHANTOM Suture Anchors
K242895 · Aevumed, Inc. · Aug 2025
Iconix Speed Anchor
K252144 · Riverpoint Medical · Jul 2025
OTS 25-L (100-5)
K251310 · Ots Medical , Ltd. · Jul 2025