# K102843: Mac Male Adapter

- Pathway: 510(k) (Special)
- Applicant: Biomet Trauma (Aka Ebi, LLC)
- Decided: May 3, 2011 after 216 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K993886 (1999). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021695: Ebi Dynafix Diaphyseal Correction System, Ebi, L.P. (2002) Summary page 2.
- K030372: Modification to Ebi Dynafix Diaphyseal Correction System, Ebi, L.P. (2003) Summary page 2.
- K081244: Lower Extremity External Fixation - Expanded Indications, Biomet Trauma (2008) Summary page 2.

## Indications for use
The MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K102843
Methodology: https://510kreport.com/methodology