# K131980: Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Sep 4, 2013 after 68 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: 2 generations back to K021564 (2002). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310), Abbott Spine, Inc. (2008) Summary page 1.
- K023644: Modification to Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 1.
- K915478: Sensicare Synthetic Medical Gloves, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992)
- K946348: Titanium TSRH (R) Spinal System (Screws), Sofamor Danek USA,Inc. (1995) Summary page 1.

## Most influential descendants
- K203507: Vitality® Spinal Fixation System (2021), 8 descendants of its own
- K230116: Vital™ Spinal Fixation System (2023), 5 descendants of its own
- K240539: Vital™ Spinal Fixation System (2024), 4 descendants of its own
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), 2 descendants of its own
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own

## Indications for use
When intended for pedicle screw fixation from Ti-S1, the Sequoia® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established. When intended for non-pedicle, posterior screw fixation of the non-cervical spine (Ti-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

Source page: https://510kreport.com/device/K131980
Methodology: https://510kreport.com/methodology