# K051323: Merete Twistcut Snap-Off Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Jul 7, 2005 after 48 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: 3 generations back to K924138 (1993). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971069: Twist-Off (TM) Screw, Landos, Inc. (1997) Summary page 1.
- K011946: The Spin Snap-Off Screw, New Deal, S.A. (2001) Summary page 1.

## Most influential descendants
- K170012: Foot and Hand Motion (2017), 0 descendants of its own
- K152187: MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws (2016), 0 descendants of its own

## Indications for use
The Merete TwistCut Tm Snap-Off Bone Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of Small Bone Fragments, Weil-Osteotomy, Mono-Cortical Fixation, Osteotomies and fractures fixation in the foot and hand.

Source page: https://510kreport.com/device/K051323
Methodology: https://510kreport.com/methodology