# K210449: Infinity™ OCT System, PASS OCT® Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic
- Decided: Mar 18, 2021 after 30 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003155 (2001). 167 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163375: INFINITY™ OCT System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.
- K153169: PASS OCT Patient Specific Rods, Medicrea International (2016) Summary page 5.

## Most influential descendants
- K233078: Posterior Cervical Spine System (2023), 1 descendant of its own
- K253195: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (2026), 0 descendants of its own
- K220810: Infinity™ OCT System and PASS OCT Spinal System (2022), 0 descendants of its own

## Indications for use
The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: ▪ Traumatic spinal fractures and/or traumatic dislocations. ▪ Instability or deformity. ▪ Failed previous fusions (e.g. pseudarthrosis). ▪ Tumors involving the cervical spine. ▪ Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT® Spinal System package insert for a list of the indications of use. Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used. The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws. Note: Segmental fixation is recommended for these constructs. The PASS OCT® Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT® Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT® Spinal System may be linked to the PASS LP® Spinal System using the dual diameter rods or specific connecting components. The PASS OCT® Patient Specific Rod is to be implanted either with PASS OCT® Spinal System or with Infinity™ OCT Spinal System. Warning: mixing PASS OCT® and Infinity OCT Spinal Systems connection components is not allowed for the PASS OCT® Patient Specific Rod implantation, as the operating principle for screw attachment or fixation is unsimilar between the two systems and will cause a misalignment of the rod. Mixing lateral loading screw system and top loading screw system is prohibited. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of lower thoracic (T4-T12), or lumbar spine. CAUTION: to be used by or according to the prescription of a licensed physician. Implantation should only be performed by a surgeon who is familiar with the device, its intended use, dedicated instruments, and understands all aspects of the surgical procedure.

Source page: https://510kreport.com/device/K210449
Methodology: https://510kreport.com/methodology