# K170056: IRENE Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Zhengtian Medical Instrument Co., Ltd.
- Decided: Oct 23, 2017 after 290 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: 6 generations back to K962823 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 5.
- K100359: Darco Headed Cannulated Screw, Wrightmedicaltechnologyinc (2010) Summary page 5.

## Indications for use
IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below. Acutec Headless Compression Screw: Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcancus and other small bones. Cannulated Screw: Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.

Source page: https://510kreport.com/device/K170056
Methodology: https://510kreport.com/methodology