# K160655: OrthoButton CL

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical
- Decided: Jun 3, 2016 after 87 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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 K792022 (1979). 57 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133757: GFS II Standard, GFS II Large, GFS Mimi, Parcus Medical, LLC (2014) Summary page 4.

## Most influential descendants
- K171060: OrthoButton AL (2017), 8 descendants of its own
- K230212: OrthoButton AL (2023), 2 descendants of its own
- K240835: Suture Button Repair System (2024), 1 descendant of its own
- K202399: OrthoButton FL (2020), 1 descendant of its own
- K191319: Dunamis Fixation Button System (2019), 1 descendant of its own

## Indications for use
The Riverpoint Medical OrthoButton CL® is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Source page: https://510kreport.com/device/K160655
Methodology: https://510kreport.com/methodology