# K072672: Sequoia Spinal System, Model 3300 Series

- Pathway: 510(k) (Special)
- Applicant: Abbott Spine, Inc.
- Decided: Nov 28, 2007 after 68 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
Longest line of descent: 2 generations back to K021564 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021564: Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 1.
- K023644: Modification to Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 1.

## Recalls of this device
- Apr 4, 2011 · Not classified · Z-2705-2011: A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engag
- Feb 13, 2008 · Not classified · Z-1479-2008: Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty att

## Indications for use
When intended for pedicle screw fixation from Ti -SI, the Sequoia Thoracolumbar Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fasion 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 pedicle screw system places between L3 and SI, 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-SI), 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. When intended for anterolateral screw, rod and/or cable fixation of the T6-L5 spine, the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confinue by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. seoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants arc not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure. The use of posterior spinal instrumentation in children has been reported in the literature. The Sequoia Spinal System may be used for non-pedicle posterior use in this patient group.

Source page: https://510kreport.com/device/K072672
Methodology: https://510kreport.com/methodology