XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm— 510(k) K260073

Name: FDA 510(k) clearance K260073
Creator: U.S. Food and Drug Administration
Published: 2026-02-10

Substantially Equivalent

Biodynamik, Inc.

FDA 510(k) clearance K260073 for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm, Substantially Equivalent on 2026-02-10. Applicant: Biodynamik, Inc.. Device class: 2.

Clearance details

Applicant: Biodynamik, Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-01-09
Decision date: 2026-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDW

view all

K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System2025-10-29
K241357 — XT3 System2025-01-22
K223112 — MAVERICK Mini External Fixation System2022-12-08
K213874 — MAVERICK External Fixation System2022-02-11
K211508 — Steinmann Pins and Kirschner Wires2021-10-05

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.