Cleared Traditional

K153585 - Flip Button Suture Anchor

K153585 is the FDA 510(k) clearance for Flip Button Suture Anchor by First Ray, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K153585 · First Ray, LLC · Orthopedic device
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May 2016
Decision
141d
Days
Class 2
Risk

K153585 is an FDA 510(k) clearance for the Flip Button Suture Anchor. 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 First Ray, LLC (Logan, US). The FDA issued a Cleared decision on May 5, 2016 after a review of 141 days - within the typical 510(k) review window.

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 First Ray, LLC devices

Submission Details

510(k) Number K153585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2015
Decision Date May 05, 2016
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K153585.
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K152262 · Biomet Manufacturing Corp · Mar 2016