# K163375: INFINITY™ OCT System - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: Aug 21, 2017 after 263 days - Product code: NKG (Posterior Cervical Screw System) - Device class: 2 - Regulation: 21 CFR 888.3075 - Recalls of this device: 5 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 15 generations back to K040583 (2004). 136 ancestors in all. 16 later devices descend from it; 7 cite it directly. 0 of 153 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4. - K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 4. - K052734: Modification to: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 4. - K070742: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2007) Summary page 4. - K071942: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2007) Summary page 4. - K082728: Vertex Recontruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 4. - K090714: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 4. - K091365: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Soafamor Danek (2009) Summary page 4. - K123656: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4. - K123906: Vertex Reconstruction System, Vertext Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4. - K152338: VERTEX (r) Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4. - K162379: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4. ## Most influential descendants - K180851: VERTEX™ Reconstruction System (2018), 8 descendants of its own - K210449: Infinity™ OCT System, PASS OCT® Spinal System (2021), 3 descendants of its own - K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own - K192646: SYMPHONY™ OCT System (2020), 2 descendants of its own - K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own ## Recalls of this device - Feb 16, 2023 · Class II · Z-1413-2023: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - Feb 16, 2023 · Class II · Z-1412-2023: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - Feb 16, 2023 · Class II · Z-1410-2023: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - Feb 16, 2023 · Class II · Z-1409-2023: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - Feb 16, 2023 · Class II · Z-1411-2023: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws ## 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. 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 and VERTEX Reconstruction 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. Source page: https://510kreport.com/device/K163375 Methodology: https://510kreport.com/methodology