Not Cleared Direct

DEN220015 - Orthobond Mariner Pedicle Screw System (FDA 510(k) Clearance)

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

DEN220015 · Orthobond Coporation · Orthopedic device
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Apr 2024
Decision
767d
Days
Class 2
Risk

DEN220015 is an FDA 510(k) submission (not cleared) for the Orthobond Mariner Pedicle Screw System. Classified as Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating (product code QZY), Class II - Special Controls.

Submitted by Orthobond Coporation (Monmouth, US). The FDA issued a Not Cleared (DENG) decision on April 5, 2024 after a review of 767 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3071 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 767 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Orthobond Coporation devices

Submission Details

510(k) Number DEN220015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 28, 2022
Decision Date April 05, 2024
Days to Decision 767 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
645d slower than avg
Panel avg: 122d · This submission: 767d
Pathway characteristics

Device Classification

Product Code QZY Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3071
Definition A Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating Is A Rigid Metallic Implant System Compromised Of Single Or Multiple Components Intended To Provide Immobilization And Stabilization Of Spinal Segments As An Adjunct To Fusion In Skeletally Mature Patients. The Device Includes A 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating Intended To Reduce Microbial Contamination On The Surface Of The Device Prior To Implantation. The Device Does Not Contain Antimicrobial Agents That Act Within Or On The Body.
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.