510(k) · Cleared
ClearedMikron Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mikron Makina Sanayi Ticaret Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 12, 2017 as substantially equivalent to K130073 (Mikron Makina Sanayi VE Ticaret Ltd. Sti., 2013) and 1 other predicate after a 143-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 12, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951116 (1995). 37 ancestors in all, the oldest K884263 (1988). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 4 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 3 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 2 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 1 generation backK123476 Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013
- This deviceK171497 Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
- Descendant · 2 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250092 HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · cites it directly3descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 2 generations on1descendant
- K254247Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026 · 3 generations on0descendants
- K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −4 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −3 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −2 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −1 | K123476 | Mega 5.5 Spine System | Lsk Biopartners, Inc. | 2013 | — |
| 0 (this device) | K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co., Ltd. | 2017 | — |
| +1 | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
| +2 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +3 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
| +2 | K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2007 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130073 | Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsSummary page 5…tial Equivalence The proposed device is substantially equivalent to the device with the same trade name, Mikron Spinal Fixation System, which was FDA-cleared via 510(k) K130073, and BK Meditech's "MEGA 5.5 System" (K123476) -referred to as "Additional Predicate". These devices have the same intended use,… | 2013 |
| * | K123476 | Mega 5.5 Spine SystemSummary page 5…antially equivalent to the device with the same trade name, Mikron Spinal Fixation System, which was FDA-cleared via 510(k) K130073, and BK Meditech's "MEGA 5.5 System" (K123476) -referred to as "Additional Predicate". These devices have the same intended use, technological characteristics and basic design… | 2013 |
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 |
|---|---|---|---|
| K241657 | MSFX Mikron Spinal Fixation System | 2024 | 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 22 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 37 ancestors have a recall of any class.
- Of its descendants, K241657 (Mikron Makina Sanayi VE Ticaret Ltd. Sti., 2024) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 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 attachment of a solid fusion. Mikron Spinal Fixation System is also intended to provide immobilization and stabilization of…
Read the full statement (120 words)
Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 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 attachment of a solid fusion.
Mikron Spinal Fixation System is also 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/K171497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171497: Mikron Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171497
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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