# K231236: IBS-B MIS Beveled Screw System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Jul 27, 2023 after 90 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: 12 generations back to K000684 (2000). 96 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131920: Stabilization Screw, In2bones Sas (2014) Summary page 4.
- K162353: MICATM Screw System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K170518: In2Bones Fracture and Correction System, In2bones USA, LLC (2017) Summary page 5.
- K180377: Fracture and Correction System, In2bones USA, LLC (2018) Summary page 5.

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

## Indications for use
The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs appropriate for the size of the device.

Source page: https://510kreport.com/device/K231236
Methodology: https://510kreport.com/methodology