# K071074: Mykres Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Showa Ika Kohgyo Co., Ltd.
- Decided: Jul 2, 2008 after 443 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 K901587 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051704: Mykres Spinal System, Showa Ika Kohgyo Co., Ltd. (2006) Summary page 2.
- K032265: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 2.
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 2.
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 2.

## Indications for use
The MYKRES Spinal 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MYKRES Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. When used as an anterior, noncervical screw fixation system, the MYKRES Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, or failed fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K071074
Methodology: https://510kreport.com/methodology