MotoCLIP/HiMAX Step Staple Implant System— 510(k) K181866

Clearance details

Applicant

Crossroads Extremity Systems, LLC

Product code

Code JDR

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2018-07-12

Decision date

2018-08-09

Decision

Substantially Equivalent

Clearance type

Special

Location

Memphis, TN, US

• K262451 — Arthrex DynaNite Staples2026-09-01
• K261121 — Megalodon Dynamic Compression System2026-08-06
• K250712 — Linkt Compression Staple System2025-05-14
• K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
• K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

• K223342 — MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System2023-03-30
• K220797 — FootHold System2022-04-15
• K202268 — CrossRoads Tray System2020-12-30
• K190658 — MIS Bunion Plating System2019-04-12
• K181872 — MIS Bunion System2019-02-19

Injury

726

Malfunction

663

Other

1

Total

1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →