510(k) · Cleared
Cleared4CIS Vane Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 15, 2012 as substantially equivalent to K001668 (D.K.M. Co., Ltd., 2000) and 2 other predicates after a 75-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Aug 15, 2012
- Review
- 75 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000319 (2000). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK060702 4CIS Vane Spine SystemSolco Biomedical Co., Ltd. · 2006
- 1 generation backK101818 4CIS Vane Spine SystemSolco Biomedical Co., Ltd. · 2011
- This deviceK121615 4CIS Vane Spine SystemSolco Biomedical Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK181995 Chiral Surgical Pedicle Screw SystemChiral Surgical · 2018
Most influential descendants
Showing 1 of 1 · See all- K181995Chiral Surgical Pedicle Screw SystemChiral Surgical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K060702 | 4CIS Vane Spine System | Solco Biomedical Co., Ltd. | 2006 | — |
| −1 | K101818 | 4CIS Vane Spine System | Solco Biomedical Co., Ltd. | 2011 | — |
| 0 (this device) | K121615 | 4CIS Vane Spine System | Solco Biomedical Co., Ltd. | 2012 | — |
| +1 | K181995 | Chiral Surgical Pedicle Screw System | Chiral Surgical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (3)
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…devices, 4C15® VANE Spine System is substantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMATM, Spinal System(K031585), 4CISO VANE Spine Systeni(K1 018 18) Device Description The 4CIS® VANE Spine… | 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 OPTIMATM, Spinal System(K031585), 4CISO VANE Spine Systeni(K1 018 18) Device Description The 4CIS® VANE Spine System is a top-loading multiple com… | 2003 |
| * | K101818 | 4CIS Vane Spine SystemSummary page 1…, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMATM, Spinal System(K031585), 4CISO VANE Spine Systeni(K1 018 18) Device Description The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation sys… | 2011 |
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 |
|---|---|---|---|
| K181995 | Chiral Surgical Pedicle Screw System | 2018 | 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 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K181995 (Chiral Surgical, 2018) has gone furthest, with 0 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. 2012, 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 4C15 VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121615: 4CIS Vane Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121615
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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