Cleared Traditional

K241050 - CrossRoads Modular Tray System

K241050 is an FDA 510(k) clearance for CrossRoads Modular Tray System, manufactured by Crossroads Extremity Systems. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K241050 · Crossroads Extremity Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
90d
Days
Class 2
Risk

K241050 is an FDA 510(k) clearance for the CrossRoads Modular Tray System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Crossroads Extremity Systems (Memphis, US). The FDA issued a Cleared decision on July 16, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Crossroads Extremity Systems devices

FDA 510(k) Submission Details - K241050

510(k) Number K241050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2024
Decision Date July 16, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K241050.
Klockner Kits
K243128 · SOADCO, S.L. · Dec 2024
Guided Surgery Kit Cases
K241492 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Aug 2024
SteriTite rigid reusable sterilization container with MediTray Products
K240898 · Case Medical · Jul 2024
S.I.N. Instrument Kits
K241378 · S.I.N. ? Sistema DE Implante Nacional S.A. · Jul 2024
Perforated Baskets
K231291 · Richard Wolf Medical Instruments Corporation · Jun 2024
BAHADIR STERILIZATION CONTAINERS
K233578 · Bahadir USA, LLC · Mar 2024