510(k) · Cleared
ClearedMikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mikron Makina Sanayi VE Ticaret Ltd. Sti. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Dec 16, 2013 as substantially equivalent to K063708 (Taeyeon Medical Co., Ltd., 2007) and 1 other predicate after a 339-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Dec 16, 2013
- Review
- 339 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000319 (2000). 8 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK063708 4S Spinal SystemTaeyeon Medical Co., Ltd. · 2007
- This deviceK130073 Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws…Mikron Makina Sanayi VE Ticaret Ltd. Sti. · 2013
- Descendant · cites it directly · 4 of its ownK171497 Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
- Descendant · 3 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK250092 HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017 · cites it directly4descendants
- K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · 2 generations on3descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 3 generations on1descendant
- K254247Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026 · 4 generations on0descendants
- K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −1 | K063708 | 4S Spinal System | Taeyeon Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K130073 | Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws… | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2013 | — |
| +1 | K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co., Ltd. | 2017 | — |
| +2 | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
| +3 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +4 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
| +3 | K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K063708 | 4S Spinal SystemSummary page 1…IAL EQUIVALENCE: Mikron Spinal Fixation System is substantially equivalent to the legally marketed in function, intended use, material and design to 4S Spinal System (K(063708) and Optima Spinal System (K031585). 4 DEVICE DESCRIPTION: Mikron Spin al Fixation System is a top-loading multiple component,… | 2007 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…xation System is substantially equivalent to the legally marketed in function, intended use, material and design to 4S Spinal System (K(063708) and Optima Spinal System (K031585). 4 DEVICE DESCRIPTION: Mikron Spin al Fixation System is a top-loading multiple component, posterior spinal fixation system co… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | 2017 | 4 |
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 13 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K171497 (Mikron Makina Sanayi Ticaret Co., Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K063708.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Tbe MSFX 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 (TI to 52): severe spoudylolisthesis (grades 3 and 4) of the L5-S I vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130073: Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130073
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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