Cleared Traditional

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

K243889 · Orthocell, Ltd. · Neurology

Apr 2025

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K243889 is an FDA 510(k) clearance for the Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm), a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Orthocell, Ltd. (Murdoch, AU). The FDA issued a Cleared decision on April 2, 2025, 105 days after receiving the submission on December 18, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number	K243889 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2024
Decision Date	April 02, 2025
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF