Cleared Special

K102843 - MAC MALE ADAPTER

K102843 is an FDA 510(k) clearance for MAC MALE ADAPTER, manufactured by Biomet Trauma (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 216-day FDA review.

K102843 · Biomet Trauma (Aka Ebi, LLC) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
216d
Days
Class 2
Risk

K102843 is an FDA 510(k) clearance for the MAC MALE ADAPTER. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Biomet Trauma (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on May 3, 2011 after a review of 216 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102843

510(k) Number K102843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date May 03, 2011
Days to Decision 216 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 122d · This submission: 216d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 395
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K102843 · MAC MALE ADAPTER
Download PDF FDA Summary Biomet Trauma (Aka Eb…