# K090063: Merete Locking Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical, Inc.
- Decided: Apr 22, 2009 after 103 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 K981372 (1998). 14 ancestors in all.
241 later devices descend from it; 3 cite it directly.
0 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006). Our reading of the summary gave K067808, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DARCO Locking Plate System”.
- K063487: Merete BLP Small Fragment Locking Bone Plate, Merete Medical GmbH (2007) Summary page 1.
- K081513: Merete 3.0 and 3.5 MM Locking Screws, Merete Medical GmbH (2008) Summary page 1.

## Most influential descendants
- 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
- K120070: Synthes Variable Angle LCP Elbow System (2012), 76 descendants of its own
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) (2012), 53 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own

## Indications for use
The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.

Source page: https://510kreport.com/device/K090063
Methodology: https://510kreport.com/methodology