# DEN220015: Orthobond Mariner Pedicle Screw System

- Pathway: De Novo (Direct)
- Applicant: Orthobond Coporation
- Decided: Apr 5, 2024 after 767 days
- Product code: QZY (Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating)
- Device class: 2
- Regulation: 21 CFR 888.3071
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The intended use of the Orthobond Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: • Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, • Spondylolisthesis, • Trauma (i.e., fracture or dislocation), • Spinal stenosis, • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), • Spinal tumor, • Pseudarthrosis, and/or • Failed previous fusion. The Orthobond coating is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device. The clinical impact associated with the Orthobond coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The Orthobond coating is not intended to treat existing infections and does not act within or on the body.

Source page: https://510kreport.com/device/DEN220015
Methodology: https://510kreport.com/methodology