Cleared Traditional

VERTEX Nitinol Staple System (K182943) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182943 · Nvision Biomedical Technologies, LLC · Orthopedic device
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Apr 2019
Decision
163d
Days
Class 2
Risk

K182943 is an FDA 510(k) clearance for the VERTEX Nitinol Staple System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, LLC (San Antonio, US). The FDA issued a Cleared decision on April 4, 2019 after a review of 163 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 Nvision Biomedical Technologies, LLC devices

Submission Details

510(k) Number K182943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2018
Decision Date April 04, 2019
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Watershed Ideas Foundry
Jeffrey Brittan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDR Staple, Fixation, Bone

All 230
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K182943.
Linkt Compression Staple System
K250712 · Trax Surgical · May 2025
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
K243888 · Medline Industries, LP · Apr 2025
Arthrex DynaNite Nitinol Staples
K243742 · Arthrex, Inc. · Jan 2025
TMC Compression Implant System
K243658 · Treace Medical Concepts · Dec 2024
TMC Compression Implant System
K242415 · Treace Medical Concepts · Sep 2024
COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024