# K161535: SeaSpine® NewPort™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Sep 8, 2016 after 97 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K901587 (1990). 55 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083089: Newport Spinal System, Seaspine, Inc. (2009) Summary page 4.
- K053276: Ist Pedicle Screw System, Innovative Spinal Technologies, Inc. (2005) Summary page 4.
- K051663: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 4.
- K051942: Malibu Spinal System, Seaspine, Inc. (2005) Summary page 4.
- K061342: Malibu Spinal System, Seaspine, Inc. (2006) Summary page 4.
- K072605: Malibu Spinal System, Seaspine, Inc. (2007) Summary page 4.

## Most influential descendants
- K163604: SeaSpine® Daytona® Small Stature Spinal System (2017), 12 descendants of its own
- K183639: Mariner Outrigger Revision System (2019), 8 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own
- K203222: PERLA TL Posterior Osteosynthesis System (2020), 4 descendants of its own
- K203506: PERLA® TL posterior osteosynthesis system (2021), 3 descendants of its own

## Indications for use
The SeaSpine® NewPort™ Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: - degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, - severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion, - spondylolisthesis, - trauma (i.e., fracture or dislocation), - spinal stenosis, - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - spinal tumor, - pseudoarthrosis, and/or - failed previous fusion.

Source page: https://510kreport.com/device/K161535
Methodology: https://510kreport.com/methodology