# K081513: Merete 3.0 and 3.5 MM Locking Screws

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Jul 18, 2008 after 49 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981372 (1998). 13 ancestors in all.
256 later devices descend from it; 5 cite it directly.
0 of 270 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.
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.
- K050457: Merete Metafix Small Fragment Bone Plate System, Merete Medical GmbH (2005) Summary page 1.
- K063487: Merete BLP Small Fragment Locking Bone Plate, Merete Medical GmbH (2007) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates 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, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

Source page: https://510kreport.com/device/K081513
Methodology: https://510kreport.com/methodology