Cleared Traditional

Newclip Patient-matched instrumentation non sterile PSI

K243912 · Newclip Technics · Orthopedic

Feb 2025

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K243912 is an FDA 510(k) clearance for the Newclip Patient-matched instrumentation non sterile PSI, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Newclip Technics (Haute Goulaine, FR). The FDA issued a Cleared decision on February 13, 2025, 56 days after receiving the submission on December 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K243912 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2024
Decision Date	February 13, 2025
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.