# K252064: MedCAD® AccuStride™ System

- Pathway: 510(k) (Traditional)
- Applicant: Medcad
- Decided: Mar 27, 2026 after 269 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: 9 generations back to K924630 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241811: MedCAD® AccuStride™ System, Medcad (2025) Summary page 5.

## Indications for use
The MedCAD® AccuStride TM 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 guiding surgical instruments in non- acute, non-joint replacing osteotomies in the foot, ankle, and lower leg (tibia / fibula) for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride TM System surgical guides are intended for single use only. The MedCAD® AccuStride TM 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/K252064
Methodology: https://510kreport.com/methodology