510(k) · Cleared
ClearedMykres Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Showa Ika Kohgyo Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 2, 2008 as substantially equivalent to K051704 (Showa Ika Kohgyo Co., Ltd., 2006) and 4 other predicates after a 443-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Jul 2, 2008
- Review
- 443 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K901587 (1990). 32 ancestors in all, the oldest K873826 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 1 generation backK051704 Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd. · 2006
- This deviceK071074 Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K051704 | Mykres Spinal System | Showa Ika Kohgyo Co., Ltd. | 2006 | — |
| 0 (this device) | K071074 | Mykres Spinal System | Showa Ika Kohgyo Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051704 | Mykres Spinal SystemSummary page 2…e addition of such an indication to the statement of intended use. The MYKRES Spinal System, consisting of rods, screws, hooks, connectors and washers, was cleared under K051704 for posterior noncervical spinal fixation. Three new components are available for use in various combinations with certain compon… | 2006 |
| * | K032265 | CD Horizon Spinal SystemSummary page 2…vices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: the CD Horizon® Spinal System from Medtronic Sofamor Danek, Inc. (K032265), the Kaneda SR Anterior Spinal System and Anterior Scoliosis System from AcroMed Corp. (K971248, K974757), and the Xia Spine Sys… | 2003 |
| * | K971248 | Kaneda SR Anterior Spinal SystemSummary page 2…vices: the CD Horizon® Spinal System from Medtronic Sofamor Danek, Inc. (K032265), the Kaneda SR Anterior Spinal System and Anterior Scoliosis System from AcroMed Corp. (K971248, K974757), and the Xia Spine System from Howmedica, Inc. (K98425 1). 4 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1997 |
| * | K974757 | Kaneda Anterior Scoliosis System KassSummary page 2…e CD Horizon® Spinal System from Medtronic Sofamor Danek, Inc. (K032265), the Kaneda SR Anterior Spinal System and Anterior Scoliosis System from AcroMed Corp. (K971248, K974757), and the Xia Spine System from Howmedica, Inc. (K98425 1). 4 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1998 |
| * | K984251 | Xia Spine SystemSummary page 2…Inc. (K032265), the Kaneda SR Anterior Spinal System and Anterior Scoliosis System from AcroMed Corp. (K971248, K974757), and the Xia Spine System from Howmedica, Inc. (K98425 1). 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 32 ancestors have a recall of any class.
- 3 other devices also cite its predicate K051704.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (167 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071074: Mykres Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026