Cleared Traditional

Superelastic Staple (K192447) - FDA 510(k) Clearance

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

K192447 · Neosteo · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
175d
Days
Class 2
Risk

K192447 is an FDA 510(k) clearance for the Superelastic Staple. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Neosteo (Nantes, FR). The FDA issued a Cleared decision on February 28, 2020 after a review of 175 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 Neosteo devices

Submission Details

510(k) Number K192447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2019
Decision Date February 28, 2020
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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

The OrthoMedix Group, Inc.
J.D Webb

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 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K192447.
Ligament Staple
K210456 · Medacta International S.A. · Apr 2021
Arthrex DynaNite Nitinol Staples
K203180 · Arthrex, Inc. · Dec 2020
DynaClip Bone Staple
K193305 · MedShape, Inc. · Apr 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · Synthes USA Products, LLC · Feb 2020
TriMAX Implant System
K190722 · Crossroads Extemity Systems, LLC · Aug 2019
APTUS Foot System
K191636 · Medartis AG · Aug 2019