Cleared Traditional

K230724 - arcad 2.0 Duo & Quadro osteosynthesis c...

K230724 is an FDA 510(k) clearance for arcad 2.0 Duo & Quadro osteosynthesis c..., manufactured by Novastep. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K230724 · Novastep · Orthopedic device
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Dec 2023
Decision
263d
Days
Class 2
Risk

K230724 is an FDA 510(k) clearance for the arcad® 2.0 Duo & Quadro osteosynthesis compressive staples. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Novastep (Rennes, FR). The FDA issued a Cleared decision on December 4, 2023 after a review of 263 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 Novastep devices

FDA 510(k) Submission Details - K230724

510(k) Number K230724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2023
Decision Date December 04, 2023
Days to Decision 263 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
141d slower than avg
Panel avg: 122d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 130
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K230724.
TMC Compression Implant System
K242415 · Treace Medical Concepts · Sep 2024
COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024
A’TOMIC™ Nitinol Fixation System
K232990 · Rmr Ortho, LLC · Jan 2024
Medline UNITE® REFLEX® Nitinol Staple Kit
K232905 · Medline Industries, LP · Oct 2023
StealthFix Intraosseous Fixation System
K232324 · Medartis, Inc. · Aug 2023
Treace Medical Concepts (TMC) Compression Implant System
K232387 · Treace Medical Concepts · Aug 2023