Cleared Special

K191342 - CrossRoads Screw System

K191342 is an FDA 510(k) clearance for CrossRoads Screw System, manufactured by Crossroads Extemity Systems, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 91-day FDA review.

K191342 · Crossroads Extemity Systems, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
91d
Days
Class 2
Risk

K191342 is an FDA 510(k) clearance for the CrossRoads Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Crossroads Extemity Systems, LLC (Memphis, US). The FDA issued a Cleared decision on August 19, 2019 after a review of 91 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191342

510(k) Number K191342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2019
Decision Date August 19, 2019
Days to Decision 91 days
Submission Type Special
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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 Consultant

Mrc-X, LLC
Theresa Leister

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K191342.
SECURE Screw
K191771 · A.M. Surgical, Inc. · Oct 2019
TDM Screw Systems
K190830 · Tdm Co., Ltd. · Sep 2019
Interphalangeal Joint Fusion Device Range
K191424 · Neosteo · Aug 2019
PROSTEP™ TBI™ (Tailors Bunion Implant) System
K190970 · Wrightmedicaltechnologyinc · Aug 2019
Bone Screw Line Addition
K191289 · Vilex IN Tennessee, Inc. · Jul 2019
ActivOrtho Continuous Compression Screw System
K191817 · Activortho, Inc. · Jul 2019
K191342 · CrossRoads Screw System
Download PDF FDA Summary Crossroads Extemity S…