# K102777: Twistcut Endosorb Screws

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Dec 20, 2010 after 87 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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 K011137 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100414: Protoe Endosorb Small Hammer Toe Pin, Merete Medical GmbH (2010) Summary page 1.
- K992301: Reunite Screws, Biomet Manufacturing, Inc. (1999) Summary page 1.

## Indications for use
The TwistCutM EndloSorbTM Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures: 1. for metacarpal and phalangeal fusion and fracture 2. or repair of hallux valgus deformity (bunion).

Source page: https://510kreport.com/device/K102777
Methodology: https://510kreport.com/methodology