Cleared Traditional

K221621 - Pro-X1™ Trochanteric Nailing System (FDA 510(k) Clearance)

K221621 · X-Bolt Orthopedics · Orthopedic device

Mar 2023

Decision

276d

Days

Class 2

Risk

K221621 is an FDA 510(k) clearance for the Pro-X1™ Trochanteric Nailing System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by X-Bolt Orthopedics (Santry, IE). The FDA issued a Cleared decision on March 6, 2023, 276 days after receiving the submission on June 3, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K221621 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 2022
Decision Date	March 06, 2023
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF