Cleared Traditional

Xpert Knee

K250155 · Newclip Technics · Orthopedic
Apr 2025
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K250155 is an FDA 510(k) clearance for the Xpert Knee, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on April 23, 2025, 92 days after receiving the submission on January 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250155 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2025
Decision Date April 23, 2025
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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