Cleared Traditional

K160118 - STROPP (Single Tunnel Repair of Plantar...

K160118 is an FDA 510(k) clearance for STROPP (Single Tunnel Repair of Plantar..., manufactured by Crossroads Extremity Systems, LLC. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K160118 · Crossroads Extremity Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
105d
Days
Class 2
Risk

K160118 is an FDA 510(k) clearance for the STROPP (Single Tunnel Repair of Plantar Plate). 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 Crossroads Extremity Systems, LLC (Memphis, US). The FDA issued a Cleared decision on May 3, 2016 after a review of 105 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 Crossroads Extremity Systems, LLC devices

FDA 510(k) Submission Details - K160118

510(k) Number K160118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date May 03, 2016
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 451
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K160118.
MILAGRO ADVANCE PEEK Interference Screw
K161001 · Medos International SARL · Jun 2016
OrthoButton CL
K160655 · Riverpoint Medical · Jun 2016
FiberTak DR
K160319 · Arthrex, Inc. · May 2016
Ventix Suture Anchor
K153558 · Biomet Manufacturing Corp · Apr 2016
TRUESPAN Meniscal Repair System
K153667 · Medos International SARL · Mar 2016
Ventix Knotless Anchors
K152262 · Biomet Manufacturing Corp · Mar 2016