Cleared Traditional

K240071 - Peleton Universal Single Use Power System and Attachments (FDA 510(k) Clearance)

Class I Orthopedic device.

K240071 · Peleton Surgical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
85d
Days
Class 1
Risk

K240071 is an FDA 510(k) clearance for the Peleton Universal Single Use Power System and Attachments. Classified as Battery-powered Instruments Charged Through Sterile Barriers (product code SAM), Class I - General Controls.

Submitted by Peleton Surgical (Scottsdale, US). The FDA issued a Cleared decision on April 4, 2024 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K240071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2024
Decision Date April 04, 2024
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SAM Battery-powered Instruments Charged Through Sterile Barriers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
Definition Battery-powered Instruments Intended For Use During Surgical Procedures To Provide Power To Operate Various Accessories Or Attachments To Cut Hard Tissues (bones) And Soft Tissues. Accessories Or Attachments May Include Saw Blades, Drill Chuck, Pin Driver, And Reamer.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.