# K083089: Newport Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Jan 13, 2009 after 89 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
65 later devices descend from it; 3 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K160902: Mariner Pedicle Screw System (2016), 60 descendants of its own
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own
- K211606: Mariner Deformity System (2021), 47 descendants of its own
- K212692: Mariner Pedicle Screw System (2021), 46 descendants of its own

## Recalls of this device
- Jun 27, 2014 · Class II · Z-2182-2014: Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system
- Jun 9, 2014 · Class II · Z-1961-2014: Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially res

Source page: https://510kreport.com/device/K083089
Methodology: https://510kreport.com/methodology