# K102248: Excella II Spinal System Model EC2-00

- Pathway: 510(k) (Special)
- Applicant: Innovasis, Inc.
- Decided: Oct 7, 2010 after 59 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901587 (1990). 33 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071921: Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws), Innovasis, Inc. (2007) Summary page 1.

## Most influential descendants
- K140238: Excella Iii-D Spinal Deformity System (2014), 3 descendants of its own
- 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
- Jan 8, 2018 · Class II · Z-0644-2018: Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
- 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® Spinal System is intended for use in the non-cervical area of the spine. The INNOVASIS® Excella® Spinal System, when used for pedicle screw fixation is intended only for patients: a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass. The INNOVASIS® Excella® Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine: i. Degenerative spondylolisthesis with objective evidence of neurologic impairment; ii. Fracture; iii. Dislocation; iv. Scoliosis; v. Kyphosis; vi. Spinal tumor; and vii. Previous failed fusion (pseudoarthrosis). The INNOVASIS® Excella® Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications: i. Degenerative disc disease* ii. Spinal stenosis; iii. Spondylolisthesis; iv. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); v. Pseudoarthrosis vi. Tumor vii. Trauma (i.e. fracture or dislocation); and viii. Previous failed fusion. *(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). The INNOVASIS® Excella® Spinal System, when used for Posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: i. Degenerative disc disease; ii. Spinal stenosis; iii. Spondylolisthesis; iv. Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); v. Pseudoarthrosis vi. Tumor; vii. Trauma (i.e. fracture or dislocation); viii. Previous failed fusion. *(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).

Source page: https://510kreport.com/device/K102248
Methodology: https://510kreport.com/methodology