Cleared Traditional

K202105 - OsteoMed ExtremiFix Mini & Small System...

K202105 is an FDA 510(k) clearance for OsteoMed ExtremiFix Mini & Small System..., 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 92-day FDA review.

K202105 · Osteomed, LLC · General Hospital
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Oct 2020
Decision
92d
Days
Class 2
Risk

K202105 is an FDA 510(k) clearance for the OsteoMed ExtremiFix Mini & Small System 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 October 29, 2020 after a review of 92 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 Osteomed, LLC devices

FDA 510(k) Submission Details - K202105

510(k) Number K202105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2020
Decision Date October 29, 2020
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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
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