# K241811: MedCAD® AccuStride™ System

- Pathway: 510(k) (Traditional)
- Applicant: Medcad
- Decided: Mar 13, 2025 after 265 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: 8 generations back to K924630 (1993). 14 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K220717: RedPoint Medical's Better Bunion System, Redpoint Medical, LLC (2022) Summary page 5.

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

## Indications for use
The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient’s radiographic images (i.e., CT).

Source page: https://510kreport.com/device/K241811
Methodology: https://510kreport.com/methodology