# K050457: Merete Metafix Small Fragment Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Mar 14, 2005 after 19 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: 3 generations back to K981372 (1998). 9 ancestors in all.
258 later devices descend from it; 4 cite it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K063487: Merete BLP Small Fragment Locking Bone Plate (2007), 257 descendants of its own
- K081513: Merete 3.0 and 3.5 MM Locking Screws (2008), 256 descendants of its own
- K090063: Merete Locking Bone Plate System (2009), 241 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own

## Indications for use
The Merete MetaFix Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulnar, fibula, metacarpals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

Source page: https://510kreport.com/device/K050457
Methodology: https://510kreport.com/methodology