# K051704: Mykres Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Showa Ika Kohgyo Co., Ltd.
- Decided: Jul 3, 2006 after 374 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: 4 generations back to K901587 (1990). 24 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962757: J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod Clamp, J.B.S., S.A. (1996) Summary page 2.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 2.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 2.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 2.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 3.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.

## Most influential descendants
- K161225: Paonan Armstrong Posterior Spinal Fixation System (2017), 2 descendants of its own
- K180226: TREND II Spinal Fixation System- STEP Series (2018), 1 descendant of its own
- K173126: Arisstos™ Spinal System (2017), 1 descendant of its own
- K240233: Pitkar Spinal Pedicle Screw System (2024), 0 descendants of its own
- K241258: Ingenix Spinal System (2024), 0 descendants of its own

## 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-SI 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.

Source page: https://510kreport.com/device/K051704
Methodology: https://510kreport.com/methodology