# K042143: Excella-M Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Oct 7, 2004 after 59 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955348 (1996). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994217: Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2000) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K990745: Modification to Synthes Universal Spinal System, Synthes Spine (1999) Summary page 1.
- K012871: Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K071921: Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws) (2007), 5 descendants of its own
- K102248: Excella II Spinal System Model EC2-00 (2010), 4 descendants of its own
- 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

## Indications for use
The Innovasis 'Excella-M' Spinal System is intended for use in the non-cervical area of the spine. The Innovasis 'Excella-M' 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 sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass. The Innovasis 'Excella-M' 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: a) Degenerative spondylolisthesis with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis; e) Kyphosis; f) Spinal tumor; and g) Previous failed fusion (pseudarthrosis). The Innovasis 'Excella-M' Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications: a) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis); e) Pseudarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and h) Previous failed fusion. The Innovasis 'Excella-M' Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); e) Pseudarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and h) Previous failed fusion

Source page: https://510kreport.com/device/K042143
Methodology: https://510kreport.com/methodology