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 3, 2006 as substantially equivalent to K962757 (J.B.S., S.A., 1996) and 5 other predicates after a 374-day review. Its family tree reaches back 4 generations to 1990. 6 later devices descend from it.
- Decided
- Jul 3, 2006
- Review
- 374 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K901587 (1990). 24 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- This deviceK051704 Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK161225 Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK180226 TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK173126 Arisstos™ Spinal SystemIngenium Spine · 2017
- Descendant · 2 generations on · 0 of its ownK240233 Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK241258 Ingenix Spinal SystemIngenium Spine · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017 · cites it directly2descendants
- K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018 · cites it directly1descendant
- K173126Arisstos™ Spinal SystemIngenium Spine · 2017 · cites it directly1descendant
- K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024 · 2 generations on0descendants
- K241258Ingenix Spinal SystemIngenium Spine · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| 0 (this device) | K051704 | Mykres Spinal System | Showa Ika Kohgyo Co., Ltd. | 2006 | — |
| +1 | K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | 2017 | — |
| +1 | K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | 2018 | — |
| +1 | K173126 | Arisstos™ Spinal System | Ingenium Spine | 2017 | — |
| +2 | K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt., Ltd. | 2024 | — |
| +2 | K241258 | Ingenix Spinal System | Ingenium Spine | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (6)
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 |
|---|---|---|---|
| * | K962757 | J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking…Summary page 2…s substantially equivalent in intended use, materials, designs and operational principles to the following predicate devices: J.B.S. Spine System with Pedicle Screws (K962757) from J.B.S. (USA), Inc. SYNERGY Spinal System - Closed VLS (K974749) from Interpore Cross International. MOSS Miami Spinal… | 1996 |
| * | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Summary page 2…tional principles to the following predicate devices: J.B.S. Spine System with Pedicle Screws (K962757) from J.B.S. (USA), Inc. SYNERGY Spinal System - Closed VLS (K974749) from Interpore Cross International. MOSS Miami Spinal System (K955348, K983583, K01 11182) from DePuy AcroMed, Inc. OPTIMA… | 1998 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 2…em with Pedicle Screws (K962757) from J.B.S. (USA), Inc. SYNERGY Spinal System - Closed VLS (K974749) from Interpore Cross International. MOSS Miami Spinal System (K955348, K983583, K01 11182) from DePuy AcroMed, Inc. OPTIMA Spinal System (K031585) from U&i Corp., America. 510(k) S… | 1996 |
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 2…edicle Screws (K962757) from J.B.S. (USA), Inc. SYNERGY Spinal System - Closed VLS (K974749) from Interpore Cross International. MOSS Miami Spinal System (K955348, K983583, K01 11182) from DePuy AcroMed, Inc. OPTIMA Spinal System (K031585) from U&i Corp., America. 510(k) Summary… | 1998 |
| * | K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsSummary page 3…57 K974749 K955348, K983583, K031585 K011182 Intended Use Posterior pedicle screw and Posterior Posterior pedicle Posterior and anterior Posterior an… | 2001 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…em - Closed VLS (K974749) from Interpore Cross International. MOSS Miami Spinal System (K955348, K983583, K01 11182) from DePuy AcroMed, Inc. OPTIMA Spinal System (K031585) from U&i Corp., America. 510(k) Summary MYKRES Spinal System… | 2003 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K161225 (Paonan Biotech Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K962757.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 (110 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-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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051704: Mykres Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051704
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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