Cleared Traditional

CrossRoads Tray System (K202268) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202268 · Crossroads Extremity Systems, LLC · General Hospital
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Dec 2020
Decision
141d
Days
Class 2
Risk

K202268 is an FDA 510(k) clearance for the CrossRoads Tray System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Crossroads Extremity Systems, LLC (Memphis, US). The FDA issued a Cleared decision on December 30, 2020 after a review of 141 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, LLC devices

Submission Details

510(k) Number K202268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2020
Decision Date December 30, 2020
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 139
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K202268.
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BEGO SEMADOS Tr 58350
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Standard Sterilizable Tray
K202524 · Implant Direct Sybron Manufacturing, LLC · Jan 2021
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270 · K1 Medical, LLC · Dec 2020
NUVO Implant System – NUVO Instrument Kit Cases
K202515 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Nov 2020
Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
K182084 · Sweden & Martina S.P.A. · Nov 2020