Cleared Traditional

K173391 - OsteoMed QuickFix Hybrid MMF Sterilizat...

K173391 is an FDA 510(k) clearance for OsteoMed QuickFix Hybrid MMF Sterilizat..., manufactured by Osteomed, LLC. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K173391 · Osteomed, LLC · General Hospital
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May 2018
Decision
192d
Days
Class 2
Risk

K173391 is an FDA 510(k) clearance for the OsteoMed QuickFix Hybrid MMF Sterilization Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Osteomed, LLC (Addison, US). The FDA issued a Cleared decision on May 10, 2018 after a review of 192 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 Osteomed, LLC devices

FDA 510(k) Submission Details - K173391

510(k) Number K173391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2017
Decision Date May 10, 2018
Days to Decision 192 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
63d slower than avg
Panel avg: 129d · This submission: 192d
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 172
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K173391.
Sonicision Reusable Sterilization Tray
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Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
K173259 · Case Medical, Inc. · Jun 2018
Stryker Universal Select Sterilization Tray System
K173615 · Paragon Medical · Apr 2018
Neodent Instrument Kits
K171713 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2018
Instrument basket, for EndoEYE
K171692 · Olympus Winter & Ibe GmbH · Apr 2018