Cleared Traditional

K241927 - Synthes Graphic Case & Tray System

K241927 is an FDA 510(k) clearance for Synthes Graphic Case & Tray System, manufactured by Synthes GmbH. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K241927 · Synthes GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
270d
Days
Class 2
Risk

K241927 is an FDA 510(k) clearance for the Synthes Graphic Case & Tray System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on March 28, 2025 after a review of 270 days - an extended review cycle.

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 Synthes GmbH devices

FDA 510(k) Submission Details - K241927

510(k) Number K241927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2024
Decision Date March 28, 2025
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
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 231
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K241927.
PAL Sterilization Case
K243589 · Microaire Surgical Instruments, LLC · Jun 2025
Aesculap Aicon® Series Container System
K242762 · Aesculap, Inc. · May 2025
ONE TRAY® Sealed Sterilization Container System
K250029 · Innovative Sterilization Technologies · May 2025
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
K242564 · Prismatik Dentalcraft, Inc. · Mar 2025
Microdent Sterilization Cassette
K242023 · Implant Microdent System S.L.U. · Feb 2025
NUVENTUS NV.C™ Surgical Cassette and Tray
K243317 · Infinitum Eta, Ltd. · Feb 2025