# K170518: In2Bones Fracture and Correction System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Jul 14, 2017 after 143 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K000684 (2000). 89 ancestors in all.
15 later devices descend from it; 6 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 5.
- K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420, Syntec Scientific Corp. (1998) Summary page 5.
- K131920: Stabilization Screw, In2bones Sas (2014) Summary page 5.
- K160174: I.B.S. 2.0 Osteosynthesis screw, In2bones Sas (2016) Summary page 5.

## Most influential descendants
- 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
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own

## Recalls of this device
- Sep 9, 2026 · Class II · Z-0157-2027: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

## 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/K170518
Methodology: https://510kreport.com/methodology