# K180377: Fracture and Correction System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Jun 20, 2018 after 128 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: 11 generations back to K000684 (2000). 94 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170518: In2Bones Fracture and Correction System, In2bones USA, LLC (2017) Summary page 5.
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 5.
- K160174: I.B.S. 2.0 Osteosynthesis screw, In2bones Sas (2016) Summary page 5.
- K143460: Cannulated Screw System, Wrightmedicaltechnologyinc (2015) Summary page 5.

## Most influential descendants
- K231236: IBS-B MIS Beveled Screw System (2023), 1 descendant of its own
- K202817: GEO Bone Screw System (2020), 1 descendant of its own
- K254280: F.A.S.T Screw (2026), 0 descendants of its own
- K261154: CoLink® & CoLag® Non-Sterile Screws (2026), 0 descendants of its own
- K230946: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (2023), 0 descendants of its own

## Indications for use
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).

Source page: https://510kreport.com/device/K180377
Methodology: https://510kreport.com/methodology