510(k) · Cleared
Cleared4CIS Chiron Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 1, 2022 as substantially equivalent to K190471 (Solco Biomedical Co., Ltd., 2019) after a 576-day review. Its family tree reaches back 2 generations to 2012. 1 later device descends from it.
- Decided
- Jun 1, 2022
- Review
- 576 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K111136 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK111136 Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 2012 · Recalled
- 1 generation backK190471 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2019
- This deviceK203233 4CIS Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK231655 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K111136 | Expedium Spine System, Viper System, Viper 2 System | Depuy Spine, Inc. | 2012 | 1 |
| −1 | K190471 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2019 | — |
| 0 (this device) | K203233 | 4CIS Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2022 | — |
| +1 | K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K190471 | 4CIS® Chiron Spinal Fixation SystemSummary page 5…K203233 Page 2 of 3 4CIS® Chiron Spinal Fixation System (K190471)[Solco Biomedical Co., Ltd.] – Primary Predicate EXPEDIUM SPINE SYSTEM, VIPER SYS… | 2019 |
| † | K111136 | Expedium Spine System, Viper System, Viper 2 System | 2012 |
| † | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | 2003 |
| † | K012871 | Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176… | 2001 |
| † | K123134 | Easyspine System | 2013 |
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 |
|---|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation System | 2024 | 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 10 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K231655 (Solco Biomedical Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K190471.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The 4CIS® Chiron spinal fixation 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:
1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
2. Spondylolisthesis;
3. Trauma (i.e., fracture or dislocation);
4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
5. Tumor;
6. Stenosis;
7. Failed previous fusion (pseudoarthrosis).
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/K203233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203233: 4CIS Chiron 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/K203233
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