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.

Summary

Biodynamik lists four entries: XT3 System, XT3 System Mini, XT3 System 40mm, and XT3 System Mini 40mm. They're filed under product code JDW, threaded fixation pin, and the record doesn't describe them beyond those names.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).

Biodynamik filed from Lake Forest, California. Review took 32 calendar days (January 9 to February 10, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Biodynamik, Inc.
Product code: Product 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

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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.