# K190385: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Aug 8, 2019 after 170 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962616 (1996). 214 ancestors in all.
No later device cites it as a predicate yet.
0 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182402: CoLink View Plating System, In2bones USA, LLC (2018) Summary page 10.
- K180377: Fracture and Correction System, In2bones USA, LLC (2018) Summary page 10.
- K181113: CoLink™ Afx Plating System, In2bones USA, LLC (2018) Summary page 10.
- K173491: RTS Lesser MTP Implant System, In2bones USA, LLC (2018) Summary page 10.
- K172300: CoLink View Plating System, In2bones USA, LLC (2017) Summary page 10.
- K170518: In2Bones Fracture and Correction System, In2bones USA, LLC (2017) Summary page 10.
- K163293: Colink™ Plating System, In2bones USA, LLC (2017) Summary page 10.
- K161426: NeoSpan Compression Staple Impant w/instruments, In2bones USA, LLC (2016) Summary page 10.
- K153609: RTS Flexible 1 MPJ Implant w/Grommets, In2bones USA, LLC (2016) Summary page 10.

## Indications for use
The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. The In2Bones USA LLC, CoLink™ Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients. 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). The In2Bones NeoSpan® Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis. The RTS® Flexible 1ST MPJ Implant w/Grommets is intended for use in the treatment of: • Hallux limitus or hallux rigidus • Painful rheumatoid arthritis • Hallux abducto valgus associated with arthritis • Unstable or painful joint from previous surgery The RTS® Lesser MTP Implant is intended for use in the treatment of: • Partial or complete dislocation of the lesser metatarsophalangeal joint • Pain associated with either rheumatoid or osteoarthritis • Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint • Stiffness at the lesser metatarsophalangeal joint associated with joint disease • Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.

Source page: https://510kreport.com/device/K190385
Methodology: https://510kreport.com/methodology