# K170594: I.B.S. osteosynthesis screws

- Pathway: 510(k) (Special)
- Applicant: In2bones Sas
- Decided: May 10, 2017 after 71 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: 7 generations back to K962823 (1996). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 5.
- K082874: Biodrive Cannulated Screw System, Biomet Trauma (2009) Summary page 5.
- K160174: I.B.S. 2.0 Osteosynthesis screw, In2bones Sas (2016) Summary page 5.
- K131920: Stabilization Screw, In2bones Sas (2014) Summary page 4.
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 5.

## Most influential descendants
- K254280: F.A.S.T Screw (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K170594
Methodology: https://510kreport.com/methodology