# K261154: CoLink® & CoLag® Non-Sterile Screws

- Pathway: 510(k) (Special)
- Applicant: In2Bones USA, LLC
- Decided: May 30, 2026 after 52 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: 17 generations back to K962616 (1996). 226 ancestors in all.
No later device cites it as a predicate yet.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181113: CoLink™ Afx Plating System, In2bones USA, LLC (2018) Summary page 6.
- K210060: CoLink Mfx Implant System, In2bones USA, LLC (2021) Summary page 6.
- K180377: Fracture and Correction System, In2bones USA, LLC (2018) Summary page 6.

## Indications for use
The In2Bones USA CoLink Non-Sterile screws when used in conjunction with compatible plating systems are indicated for: CoLink T8 2.7mm Screws: When used with the CoLink Afx Plating System: Stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula in both pediatric and adult patients. CoLink T15 3.0mm Screws: When used with the CoLink Mfx System: Stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries. ColLink T15 3.5mm Screws: When used with the CoLink Afx Plating System: Stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula in both pediatric and adult patients in both pediatric and adult patients. When used with the CoLink Mfx Plating System: Stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries in both pediatric and adult patients. The In2Bones USA Colag Non-sterile screws, when used in conjunction with compatible plating systems or used independently in a lag screw technique are indicated for: Colag T8 3.0mm Screws: When used with the Colag Fracture and Correction System: 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). ColLag T15 4.0mm Screws: When used with the Colag Fracture and Correction System: 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). When used with the CoLink® Mfx System: Stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries in both pediatric and adult patients.

Source page: https://510kreport.com/device/K261154
Methodology: https://510kreport.com/methodology