510(k) · Cleared
Cleared4S Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taeyeon Medical Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 24, 2007 as substantially equivalent to K001668 (D.K.M. Co., Ltd., 2000) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 2000. 8 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 132 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000319 (2000). 7 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK063708 4S Spinal SystemTaeyeon Medical Co., Ltd. · 2007
- Descendant · cites it directly · 5 of its ownK130073 Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws…Mikron Makina Sanayi VE Ticaret Ltd. Sti. · 2013
- Descendant · 2 generations on · 4 of its ownK171497 Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
- Descendant · 4 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · 5 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130073Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2013 · cites it directly5descendants
- K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017 · 2 generations on4descendants
- K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · 3 generations on3descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 4 generations on1descendant
- K254247Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| 0 (this device) | K063708 | 4S Spinal System | Taeyeon Medical Co., Ltd. | 2007 | — |
| +1 | K130073 | Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws… | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2013 | — |
| +2 | K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co., Ltd. | 2017 | — |
| +3 | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
| +4 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +5 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K001668 | Global Spinal Fixation SystemSummary page 1…ect device, 4S TM SPINAL SYSTEM, is substantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMAT', Spinal System(K031585) Device Description The 4S T SPINAL SYSTEM is a top-loading multiple component, pos… | 2000 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…ubstantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMAT', Spinal System(K031585) Device Description The 4S T SPINAL SYSTEM is a top-loading multiple component, posterior spinal fixation system… | 2003 |
What descends from it? (8)
3 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 7 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K130073 (Mikron Makina Sanayi VE Ticaret Ltd. Sti., 2013) has gone furthest, with 5 descendants of its own.
- 15 other devices also cite its predicate K001668.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The 4 STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI 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 4 STM SPINAL SYSTEM is intended to provide immobilization and stabilization of spinal…
Read the full statement (123 words)
The 4 STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI 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 4 STM 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 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/K063708 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063708: 4S Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063708
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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