# K152187: MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Feb 12, 2016 after 191 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: 8 generations back to K981372 (1998). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081513: Merete 3.0 and 3.5 MM Locking Screws, Merete Medical GmbH (2008) Summary page 5.
- K120787: Merete Locking Bone Plate System Iii, Merete Medical GmbH (2012) Summary page 5.
- K140069: Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0, Merete Medical GmbH (2014) Summary page 5.
- K130400: Meretec CS, Cortical Screws, Merete Medical GmbH (2013) Summary page 5.
- K091798: Merete Compression Screws, Merete Medical GmbH (2009) Summary page 5.
- K050924: Merete Duothreadtm Bone Screw, Merete Medical GmbH (2005) Summary page 5.
- K051323: Merete Twistcut Snap-Off Bone Screw, Merete Medical GmbH (2005) Summary page 5.

## Indications for use
Indications for use include fixation of fractures. For specific screw indications please see below. MetaFix™ LS Locking Screws • For adult and pediatric patients • In combination with Merete Locking Plates • Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals • Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone Merete® Cannulated PCS • For adult and pediatric patients • Fixation of fresh fractures • Revision procedures • Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes Merete® CS Cortical Screws • For adult and pediatric patients • Fixation of fresh fractures • Revision procedures • Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes Merete® Cannulated HCS • Fixation of fractures and reconstruction of various bones • Osteotomies in the foot (as Hallux Valgus) or hand • Athrodesis in hand, foot or ankle surgery • Fixation of bone fragments in long bones or small bone fractures DuoThread™ Scarf Screws • Small bone fracture fixation • Fixation and stabilization of bones of the feet • Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing Wedge Osteotomy) • Fusion (MPG-Athrodesis) • Fixation of almost all common osteotomies of the first metatarsal TwistCut™ Snap-Off Screws • Fixation of fractures and reconstruction of bones • Fixation of small bone fragments • Mono cortical fixation • Osteotomies (Weil-Osteotomy) • Fracture fixation in the foot and hand

Source page: https://510kreport.com/device/K152187
Methodology: https://510kreport.com/methodology