Cleared Abbreviated

Nexis® compressive screws (K223468) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K223468 · Novastep · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
286d
Days
Class 2
Risk

K223468 is an FDA 510(k) clearance for the Nexis® compressive screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Novastep (Rennes, FR). The FDA issued a Cleared decision on August 30, 2023 after a review of 286 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Novastep devices

Submission Details

510(k) Number K223468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2022
Decision Date August 30, 2023
Days to Decision 286 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 122d · This submission: 286d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 416
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K223468.
Accelerate Compression Screw System-Small Product Code ACC-S
K230946 · Trax Surgical · Sep 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
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Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K231819 · Innovate Orthopaedics Limited · Sep 2023
IBS-B MIS Beveled Screw System
K231236 · In2bones USA, LLC · Jul 2023
Forma Medical Headless Compression Screw
K230945 · Forma Medical, Inc. · Jul 2023
OsteoCentric ACL Fixation System
K230595 · OsteoCentric Technologies · Jun 2023