# K013775: Twinfix Interfragmentary Compression Screw System

- Pathway: 510(k) (Special)
- Applicant: Stryker Leibinger
- Decided: Jan 8, 2002 after 56 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 1 generation back to K961498 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961498: Resch Arthroscopic and Percutaneous Screw Fixation System (a.S.F.), Howmedica, Inc. (1997) Summary page 2.

## Most influential descendants
- K063244: Arc Surgical Bone Reduction Screw (2006), 1 descendant of its own
- K111608: Slic Screw Repair System (2011), 0 descendants of its own

## Indications for use
The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.

Source page: https://510kreport.com/device/K013775
Methodology: https://510kreport.com/methodology