# K220717: RedPoint Medical's Better Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Redpoint Medical, LLC
- Decided: Jun 9, 2022 after 90 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- 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: 7 generations back to K924630 (1993). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163156: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, Materialise NV (2017) Summary page 4.
- K211244: VSP® Orthopedics System, 3D Systems (2021) Summary page 4.

## Most influential descendants
- K241811: MedCAD® AccuStride™ System (2025), 2 descendants of its own
- K252064: MedCAD® AccuStride™ System (2026), 0 descendants of its own
- K251709: MedCAD® AccuStride™ System (2025), 0 descendants of its own

## Indications for use
The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.

Source page: https://510kreport.com/device/K220717
Methodology: https://510kreport.com/methodology