510(k) · Cleared
Cleared4CIS Solar Spine System and 4CIS Apollon Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 13, 2011 as substantially equivalent to K001668 (D.K.M. Co., Ltd., 2000) and 1 other predicate after a 290-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- Jun 13, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000319 (2000). 7 ancestors in all. 4 later devices descend from it, 1 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 deviceK102458 4CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK202498 4CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited · 2021
- Descendant · 2 generations on · 1 of its ownK242827 A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK262067 iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK232607 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE…Solco Biomedical Copany India Private Limited · 2024
Most influential descendants
Showing 4 of 4 · See all- K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited · 2021 · cites it directly3descendants
- K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025 · 2 generations on1descendant
- K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026 · 3 generations on0descendants
- K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited · 2024 · 2 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) | K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine System | Solco Biomedical Co., Ltd. | 2011 | — |
| +1 | K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine System | Solco Biomedical Company India Private Limited | 2021 | — |
| +2 | K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025 | — |
| +3 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | — |
| +2 | K232607 | 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW… | Solco Biomedical Copany India Private Limited | 2024 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | K001668 | Global Spinal Fixation SystemSummary page 1…nd 4CISO APOLLON Spine System, are substantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation Systemn(K001668) and OPTIMATM, Spinal Systemn(K03 1585). Device Description The 4C15® SOLAR Spine Systemn and 4C15® APOLLON Spi… | 2000 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…stantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation Systemn(K001668) and OPTIMATM, Spinal Systemn(K03 1585). Device Description The 4C15® SOLAR Spine Systemn and 4C15® APOLLON Spine System are a top- loading multiple… | 2003 |
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 |
|---|---|---|---|
| K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine System | 2021 | 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 11 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, K202498 (Solco Biomedical Company India Private Limited, 2021) has gone furthest, with 3 descendants of its own.
- 15 other devices also cite its predicate K001668.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 4C15® SOLAR Spine System and 4C15® APOLLON Spine System are a 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 4C15® SOLAR Spine System and 4C15® APOLLON Spine…
Read the full statement (133 words)
The 4C15® SOLAR Spine System and 4C15® APOLLON Spine System are a 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 4C15® SOLAR Spine System and 4C15® APOLLON Spine System are 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/K102458 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102458: 4CIS Solar Spine System and 4CIS Apollon Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102458
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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