Newclip Patient-matched instrumentation non sterile PSI

FDA 510(k) K250767 · Newclip Technics

Substantially Equivalent

510(k) numberK250767

Submission

Device name
Newclip Patient-matched instrumentation non sterile PSI
Applicant
Newclip Technics
Haute Goulaine, FR
Received
March 13, 2025
Decision date
October 1, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PBF – Orthopaedic Surgical Planning And Instrument Guides
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic

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.

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K241811MedCAD® AccuStride™ SystemPBF · Traditional Medcad03/13/2025SE
K243912Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional Newclip Technics02/13/2025SE
K240415Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional Newclip Technics11/07/2024SE
K240113CORIOGRAPH Knee Pre-Op PlanPBF · Traditional Smith & Nephew, Inc.03/18/2024SE

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K243912Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional 02/13/2025SE
K240415Newclip Patient-matched instrumentation non sterile PSIPBF · Traditional 11/07/2024SE
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Questions and answers

When was Newclip Patient-matched instrumentation non sterile PSI cleared by the FDA?

Newclip Patient-matched instrumentation non sterile PSI (K250767) received a 510(k) decision of Substantially Equivalent on October 1, 2025, 202 days after the submission was received.

What is the product code of K250767?

The FDA product code is PBF – Orthopaedic Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 888.3030.