510(k) · Cleared
Cleared4CIS® Marlin ACIF Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Feb 16, 2017 as substantially equivalent to K120275 (Synthes (Usa), LLC, 2012) and 4 other predicates after a 174-day review. Its family tree reaches back 14 generations to 2001. 1 later device descends from it.
- Decided
- Feb 16, 2017
- Review
- 174 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K003155 (2001). 100 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK162402 4CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK192044 4CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd. · 2019
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK162402 4CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K120275 | Synthes Acis/Vertebral Spacer CR | Synthes (Usa), LLC | 2012 | — |
| 0 (this device) | K162402 | 4CIS® Marlin ACIF Cage System | Solco Biomedical Co., Ltd. | 2017 | — |
| +1 | K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 17 | 0 |
| 2005 | 9 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 13 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K120275 | Synthes Acis/Vertebral Spacer CRSummary page 4…e Regulatory Class Regulation Number Intervertebral Fusion Device With Bone Graft, Cervical ODP Class II 888.3080 Predicate Device SYNTHES ACIS/VERTEBRAL SPACER CR (K120275, Primary) Endoskeleton® TC (K100889, Additional) PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional) Phantom™ Plus (K082801, Ad… | 2012 |
| * | K100889 | Endoskeleton TCSummary page 4…Intervertebral Fusion Device With Bone Graft, Cervical ODP Class II 888.3080 Predicate Device SYNTHES ACIS/VERTEBRAL SPACER CR (K120275, Primary) Endoskeleton® TC (K100889, Additional) PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional) Phantom™ Plus (K082801, Additional) TRYPTIK Ca (K091873, Addit… | 2010 |
| * | K072991 | Patriot Spacers: Colonial AcdfSummary page 4…al ODP Class II 888.3080 Predicate Device SYNTHES ACIS/VERTEBRAL SPACER CR (K120275, Primary) Endoskeleton® TC (K100889, Additional) PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional) Phantom™ Plus (K082801, Additional) TRYPTIK Ca (K091873, Additional) The predicate devices have not been subject t… | 2008 |
| * | K082801 | Phantom Plus Cage SystemSummary page 4…e Device SYNTHES ACIS/VERTEBRAL SPACER CR (K120275, Primary) Endoskeleton® TC (K100889, Additional) PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional) Phantom™ Plus (K082801, Additional) TRYPTIK Ca (K091873, Additional) The predicate devices have not been subject to a design related recall. Descript… | 2008 |
| * | K091873 | Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSummary page 4…PACER CR (K120275, Primary) Endoskeleton® TC (K100889, Additional) PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional) Phantom™ Plus (K082801, Additional) TRYPTIK Ca (K091873, Additional) The predicate devices have not been subject to a design related recall. Description of Device 4CIS®Marlin ACIF ca… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192044 | 4CIS Marlin PEEK ACIF Cage | 2019 | 0 |
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 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 8 of the 100 ancestors have a recall of any class.
- Of its descendants, K192044 (Solco Biomedical Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K120275.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be…
Read the full statement (126 words)
4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.
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/K162402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162402: 4CIS® Marlin ACIF Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162402
Report an extraction error
Are you the manufacturer?
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