Cleared Traditional

K240415 - Newclip Patient-matched instrumentation non sterile PSI

K240415 is an FDA 510(k) clearance for Newclip Patient-matched instrumentation..., manufactured by Newclip Technics. The device is a Class 2 Orthopedic device with product code PBF cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K240415 · Newclip Technics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
269d
Days
Class 2
Risk

K240415 is an FDA 510(k) clearance for the Newclip Patient-matched instrumentation non sterile PSI. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by Newclip Technics (Haute Goulaine, FR). The FDA issued a Cleared decision on November 7, 2024 after a review of 269 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Newclip Technics devices

FDA 510(k) Submission Details - K240415

510(k) Number K240415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2024
Decision Date November 07, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 122d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBF Device Classification - Class 2, Special Controls

Product Code PBF Orthopaedic Surgical Planning And Instrument Guides
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PBF Orthopaedic Surgical Planning And Instrument Guides

All 26
Devices cleared under the same product code (PBF) and FDA review panel - the closest regulatory comparables to K240415.
CORIOGRAPH Pre-Op Planning and Modeling Services
K250921 · Blue Belt Technologies, Inc. · Jun 2025
MedCAD® AccuStride™ System
K241811 · Medcad · Mar 2025
Newclip Patient-matched instrumentation non sterile PSI
K243912 · Newclip Technics · Feb 2025
CORIOGRAPH Knee Pre-Op Plan
K240113 · Smith & Nephew, Inc. · Mar 2024
Fine Osteotomy™
K240066 · Bodycad Laboratories, Inc. · Feb 2024
Newclip Patient-matched instrumentation non sterile PSI
K221615 · Newclip Technics · Oct 2023