# K140238: Excella Iii-D Spinal Deformity System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: May 7, 2014 after 97 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: 9 generations back to K990745 (1999). 68 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have 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 2.
- K071921: Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws), Innovasis, Inc. (2007) Summary page 2.
- K042143: Excella-M Spinal System, Innovasis, Inc. (2004) Summary page 2.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 2.

## Most influential descendants
- K241276: Vector™ Pedicle Screw System (2024), 1 descendant of its own
- K251073: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (2025), 0 descendants of its own
- K162143: FixxSure® X-Link (2016), 0 descendants of its own

## Recalls of this device
- Dec 7, 2015 · Class II · Z-0662-2016: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
- Jul 7, 2014 · Class II · Z-2067-2014: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

## Indications for use
The Innovasis Excella Il-D Spinal Deformity System, when used as a posterior 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 (DOD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenemative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis. kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. The Innovasis Excella llI-D Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis (Grades 3 & 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bonc graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3-sacrum/ilium. When used as Aposterior non-pedicle screw fixation system, the Innovasis Excella 1l-D3 Spinal Deformity System is intended for the treatment of 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, Scheuermann's disease), fracture. pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are TI-sacrum/ilium. When used as an anterolateral thoracolumbar system, the Innovasis Excella lll-D Spinal Deformity System is intended for anterolateral screw fixation for the following indications: Degenerative disc disease (ODD-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 or dislocation of the thoracolumbar spine, pseudoarthrosis. tumor resection, and/or failed previous fusion. Levels of screw fixation are TS-L5.

Source page: https://510kreport.com/device/K140238
Methodology: https://510kreport.com/methodology