510(k) · Cleared
ClearedMSFX Mikron Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mikron Makina Sanayi VE Ticaret Ltd. Sti. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 30, 2024 as substantially equivalent to K171497 (Mikron Makina Sanayi Ticaret Co., Ltd., 2017) and 3 other predicates after a 112-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 30, 2024
- Review
- 112 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K950697 (1995). 78 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 2 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 1 generation backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- This deviceK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
- Descendant · cites it directly · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250092 HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −5 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −2 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −1 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| 0 (this device) | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
| +1 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +2 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
| +1 | K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 10 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K171497 | Mikron Spinal Fixation SystemSummary page 5….3070 Product Code(s) NKB, KWP I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K171497 Mikron Spinal Fixation system NKB K212220 Artfx Spinal Fixation System NKB K091445 CD HORIZON SPINAL SYSTEM NKB K071373 XIA 3 Spi… | 2017 |
| * | K212220 | ArtFX Spinal Fixation SystemSummary page 5…arketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K171497 Mikron Spinal Fixation system NKB K212220 Artfx Spinal Fixation System NKB K091445 CD HORIZON SPINAL SYSTEM NKB K071373 XIA 3 Spinal System NKB Device Description Summary… | 2023 |
| * | K091445 | CD Horizon Spinal SystemSummary page 5…)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K171497 Mikron Spinal Fixation system NKB K212220 Artfx Spinal Fixation System NKB K091445 CD HORIZON SPINAL SYSTEM NKB K071373 XIA 3 Spinal System NKB Device Description Summary 21 CFR 807.92(a)(4) Msfx Mikron Spinal F… | 2010 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 5…(Primary Predicate is listed first) Product Code K171497 Mikron Spinal Fixation system NKB K212220 Artfx Spinal Fixation System NKB K091445 CD HORIZON SPINAL SYSTEM NKB K071373 XIA 3 Spinal System NKB Device Description Summary 21 CFR 807.92(a)(4) Msfx Mikron Spinal Fixation System is a top-loading, mult… | 2007 |
What descends from it? (3)
2 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 29 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 78 ancestors have a recall of any class.
- Of its descendants, K243946 (Effortmed, LLC, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: -Degenerative disc disease (DDD) (defined as back pain of discogenic…
Read the full statement (99 words)
MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior,
noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to
provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following
acute and chronic instabilities or deformities:
-Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of
the disc confirmed by history and radiographic studies).
-Spondylolisthesis
-Trauma (i.e. fracture or dislocation)
-Spinal stenosis
-Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
-Tumor
-Pseudoarthrosis; and failed previous fusion
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/K241657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241657: MSFX 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/K241657
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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