510(k) · Cleared
ClearedTyche Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyung Won Medical Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 30, 2010 as substantially equivalent to K024096 (U&I Corp., America, 2003) and 1 other predicate after a 138-day review. Its family tree reaches back 5 generations to 2000. 4 later devices descend from it.
- Decided
- Jun 30, 2010
- Review
- 138 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000319 (2000). 10 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK050471 4CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd. · 2005
- 1 generation backK082453 4CIS Solar and Apollon Spine SystemsSolco Biomedical Co., Ltd. · 2008
- This deviceK100373 Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK120353 Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK143110 GALAXY MIS Screw SystemBm Korea · 2015
- Descendant · 3 generations on · 1 of its ownK201788 EDEN Spinal Fixation SystemJmt Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK230762 EDEN Spinal Fixation MIS SystemJmt Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd. · 2012 · cites it directly3descendants
- K143110GALAXY MIS Screw SystemBm Korea · 2015 · 2 generations on2descendants
- K201788EDEN Spinal Fixation SystemJmt Co., Ltd. · 2022 · 3 generations on1descendant
- K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K050471 | 4CIS Solar Spine System and 4CIS Apollon Spine System | Solco Biomedical Co., Ltd. | 2005 | — |
| −1 | K082453 | 4CIS Solar and Apollon Spine Systems | Solco Biomedical Co., Ltd. | 2008 | — |
| 0 (this device) | K100373 | Tyche Pedicle Screw System | Kyung Won Medical Co., Ltd. | 2010 | — |
| +1 | K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw System | Bm Korea Co., Ltd. | 2012 | — |
| +2 | K143110 | GALAXY MIS Screw System | Bm Korea | 2015 | — |
| +3 | K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | 2022 | — |
| +4 | K230762 | EDEN Spinal Fixation MIS System | Jmt Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 MNH? 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? (2)
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 |
|---|---|---|---|
| * | K024096 | Optima, Spinal SystemSummary page 1…ect Tyche ' Pedicle Screw System is substantially equivalent in function, design, composition, labecling,- and intended use to: OPTIMATIM Spinal System - 1(024096 4CISY SOLAR SPINE SYSTEM - K082453) The substantial equivalence of this device is based on equivalence in intended us… | 2003 |
| * | K082453 | 4CIS Solar and Apollon Spine SystemsSummary page 1…stantially equivalent in function, design, composition, labecling,- and intended use to: OPTIMATIM Spinal System - 1(024096 4CISY SOLAR SPINE SYSTEM - K082453) The substantial equivalence of this device is based on equivalence in intended use. materials, designs and operati… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw System | 2012 | 3 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K120353 (Bm Korea Co., Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 29 other devices also cite its predicate K024096.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, The Tyche® Pedicle Screw System is intended to provide…
Read the full statement (124 words)
The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, The Tyche® Pedicle Screw 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100373: Tyche Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100373
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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