# K102845: Mahe Fixation Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Mahe Medical GmbH
- Decided: May 13, 2011 after 226 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 7 generations back to K962823 (1996). 41 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083654: Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V Alloy, CP Grade Titanium), Zimmer, Inc. (2009) Summary page 1.
- K082527: Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws, Zimmer, Inc. (2008) Summary page 1.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 1.
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 1.

## Most influential descendants
- K172943: Flex-Thread Fibula Pin System (2017), 4 descendants of its own
- K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System (2021), 3 descendants of its own
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis (2012), 2 descendants of its own
- K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System (2021), 1 descendant of its own
- K202764: Ortho Solutions Plating System (2020), 1 descendant of its own

## Indications for use
The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.

Source page: https://510kreport.com/device/K102845
Methodology: https://510kreport.com/methodology