Cleared Traditional

OsteoMed QuickFix Hybrid MMF Sterilization Tray (K173391) - FDA 510(k) Clearance

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

K173391 · Osteomed, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K173391.
Sonicision Reusable Sterilization Tray
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Straumann BLX Surgical Cassette
K180791 · Institut Straumann AG · Jun 2018
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