# K251709: MedCAD® AccuStride™ System

- Pathway: 510(k) (Traditional)
- Applicant: Medcad
- Decided: Nov 4, 2025 after 154 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). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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.
- K131445: Osteomed Extremilock Foot Plating System, Osteomed LP (2013) Summary page 5.

## Indications for use
Surgical Guides and Anatomical Models: The MedCAD® AccuStride™ System surgical guides and anatomical models are intended to be used as surgical instruments 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 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). Fixation Plates: The MedCAD® AccuStride™ System fixation plates are indicated for use in trauma, general surgery, and reconstructive procedures of the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System fixation plates are intended for single use only. The MedCAD® AccuStride™ System fixation plates 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/K251709
Methodology: https://510kreport.com/methodology