# K081165: Ellipse Lumbar Posterior Osteosynthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Dec 17, 2008 after 237 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011437 (2001). 2 ancestors in all.
19 later devices descend from it; 12 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K093170: Romeo Posterior Osteosynthesis System (2009), 18 descendants of its own
- K101678: Romeo Posterior Osteosynthesis System (2010), 16 descendants of its own
- K112108: Romeo Posterior Osteosynthesis System (2011), 13 descendants of its own
- K111127: Romeo Posterior Osteosynthesis System (2011), 13 descendants of its own
- K130267: Romeo Posterior Osteosynthesis System (2013), 12 descendants of its own

## Indications for use
ELLIPSE posterior osteosynthesis system Is Intended to use In the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE Is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed after the development of a solid fusion mass. When use as a pedicle screw fixation system, ELLIPSE is also 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 (Ti- Si): degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K081165
Methodology: https://510kreport.com/methodology