# K241276: Vector™ Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: May 20, 2024 after 14 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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: 18 generations back to K040583 (2004). 350 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 352 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102248: Excella II Spinal System Model EC2-00, Innovasis, Inc. (2010) Summary page 4.
- K140238: Excella Iii-D Spinal Deformity System, Innovasis, Inc. (2014) Summary page 4.
- K161014: NuVasive® Reline® System, Nu Vasive, Incorporated (2016) Summary page 4.

## Most influential descendants
- K251073: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (2025), 0 descendants of its own

## Recalls of this device
- May 22, 2026 · Class II · Z-2859-2026: Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition whi

## Indications for use
When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ 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 (DDD — defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture, dislocation, failed previous fusion (pseudoarthrosis), and/or tumor resection. When used for posterior non-cervical screw fixation in pediatric patients, the Innovasis Vector Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AlS). Additionally, the Innovasis Vector Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K241276
Methodology: https://510kreport.com/methodology