Cleared Traditional

K153558 - Ventix Suture Anchor

K153558 is an FDA 510(k) clearance for Ventix Suture Anchor, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K153558 · Biomet Manufacturing Corp · Orthopedic device
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Apr 2016
Decision
129d
Days
Class 2
Risk

K153558 is an FDA 510(k) clearance for the Ventix 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 Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on April 21, 2016 after a review of 129 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 Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K153558

510(k) Number K153558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2015
Decision Date April 21, 2016
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 565
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K153558.
FiberTak DR
K160319 · Arthrex, Inc. · May 2016
Flip Button Suture Anchor
K153585 · First Ray, LLC · May 2016
STROPP (Single Tunnel Repair of Plantar Plate)
K160118 · Crossroads Extremity Systems, LLC · May 2016
Elite SPK, Compasso, Elite SPK Kit
K160500 · Ncs Lab Srl · Apr 2016
TRUESPAN Meniscal Repair System
K153667 · Medos International SARL · Mar 2016
Ventix Knotless Anchors
K152262 · Biomet Manufacturing Corp · Mar 2016