Cleared Traditional

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors (K230094) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230094 · Responsive Arthroscopy, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
225d
Days
Class 2
Risk

K230094 is an FDA 510(k) clearance for the Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors. 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 Responsive Arthroscopy, LLC (Minneapolis, US). The FDA issued a Cleared decision on August 25, 2023 after a review of 225 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 Responsive Arthroscopy, LLC devices

Submission Details

510(k) Number K230094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2023
Decision Date August 25, 2023
Days to Decision 225 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 122d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K230094.
Q-FIX ULTRA All-Suture Anchor
K232457 · Smith & Nephew · Sep 2023
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
K232340 · Arthrex, Inc. · Sep 2023
AlphaVent Suture Anchors
K231093 · Stryker Endoscopy · Aug 2023
Grappler Suture Anchor System
K231867 · Paragon 28, Inc. · Aug 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
K231376 · Smith & Nephew, Inc. · Aug 2023
Arthrex TightRope II
K231857 · Arthrex, Inc. · Aug 2023