# K131920: Stabilization Screw

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: May 1, 2014 after 309 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962823 (1996). 13 ancestors in all.
18 later devices descend from it; 5 cite 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)
- K050346: Stabilization Screw, New Deal, S.A. (2005) Summary page 2.
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 2.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 2.
- K071639: Qwix Positioning Screw, Newdeal Sas (2007) Summary page 2.
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 2.

## Most influential descendants
- K160174: I.B.S. 2.0 Osteosynthesis screw (2016), 17 descendants of its own
- 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

## Recalls of this device
- Jan 26, 2024 · Class II · Z-1320-2024: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm.
- Jan 26, 2024 · Class II · Z-1319-2024: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm.
- Nov 18, 2015 · Class II · Z-0397-2016: One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

## Indications for use
The I.B.S.M osteosynthesis screws are intended for: - The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs - Osteosyntheses 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/K131920
Methodology: https://510kreport.com/methodology