# K160174: I.B.S. 2.0 Osteosynthesis screw

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Oct 6, 2016 after 253 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). 15 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 5.
- K131920: Stabilization Screw, In2bones Sas (2014) Summary page 5.
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 5.

## Most influential descendants
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own
- K180377: Fracture and Correction System (2018), 7 descendants of its own
- K191535: CoLink® Mini Plating System (2019), 6 descendants of its own
- K212487: CoLink Vallux Plating System (2021), 4 descendants of its own
- K211650: The Radian MIS Bunion System (2021), 3 descendants of its own

## Indications for use
The 1.B.S.™ 2.0 Osteosynthesis screws are intended for: - The fixation of arthrodeses, osteotomies or fractures of small bones of the upper and lower limbs - Osteosynthesis requiring mono or bicortical compression The size of the chosen screw should be adapted to the specific indications.

Source page: https://510kreport.com/device/K160174
Methodology: https://510kreport.com/methodology