# K151224: Lineum OCT Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Jun 30, 2015 after 54 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953076 (1997). 4 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.

## Most influential descendants
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K172594: Proficient® Posterior Cervical Spine System (2017), 12 descendants of its own
- K182954: Salvo™ Spine System (2018), 6 descendants of its own
- K191045: Salvo™ Spine System (2019), 5 descendants of its own
- K182182: YUKON OCT Spinal System (2018), 5 descendants of its own

## Recalls of this device
- Nov 14, 2018 · Class II · Z-1735-2019: Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.

## Indications for use
The Lineum OCT Spine 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 (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic 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 Lineum OCT Spine 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 Lineum OCT Spine System can also be connected to the Biomet Polaris System via transitional rods or using the Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system’s package insert for a list of indications for use for each system.

Source page: https://510kreport.com/device/K151224
Methodology: https://510kreport.com/methodology