# K092076: Aegis & Aegis II Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Apr 2, 2010 after 267 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 5 generations back to K950697 (1995). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K053573: GSS Pedicle Screw System, GS Medical Co., Ltd. (2006) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K200267: LOSPA® IS™ Spinal Fixation System (2020), 1 descendant of its own
- K240180: Orthopeasia Spinal Fixation System (2024), 0 descendants of its own
- K132644: Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa IS Rod- Pre Bent (Standard & BU (2013), 0 descendants of its own

## Indications for use
The AEGIS and AEGIS II Spinal Systems are 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: severe spondylolisthesis (grades 3 and 4) of the L-5-Si vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system, The AEGIS and AEGIS 11Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordlosis, tumor, pseudloarthrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K092076
Methodology: https://510kreport.com/methodology