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 Nov 26, 2024 as substantially equivalent to K203233 (Solco Biomedical Co., Ltd., 2022) and 4 other predicates after a 539-day review. Its family tree reaches back 12 generations to 1984. 1 of the 81 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 26, 2024
- Review
- 539 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 80 ancestors in all. No later device cites it as a predicate yet. 1 of the 81 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK121103 LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine…Ldr Spine USA, Inc. · 2012
- 1 generation backK123134 Easyspine SystemLdr Spine USA, Inc. · 2013
- This deviceK231655 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK121103 LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine…Ldr Spine USA, Inc. · 2012
- 1 generation backK123134 Easyspine SystemLdr Spine USA, Inc. · 2013
- This deviceK231655 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −6 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −5 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −4 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −2 | K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior… | Ldr Spine USA, Inc. | 2012 | — |
| −1 | K123134 | Easyspine System | Ldr Spine USA, Inc. | 2013 | — |
| 0 (this device) | K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 12 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 1 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K203233 | 4CIS Chiron Spinal Fixation SystemSummary page 6…55 Page 2 of 3 4CIS® Chiron Spinal Fixation System (K203233)[Solco Biomedical Co., Ltd.] – Primary Predicate EXPEDIUM SPINE SYSTEM, VIPER SYS… | 2022 |
| * | K111136 | Expedium Spine System, Viper System, Viper 2 SystemSummary page 6…co Biomedical Co., Ltd.] – Primary Predicate EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136) [DEPUY SPINE, INC.] – Additional Predicate MOSS MIAMI SPINAL SYSTEM (K030383) [D… | 2012 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 6…EM, VIPER 2 SYSTEM (K111136) [DEPUY SPINE, INC.] – Additional Predicate MOSS MIAMI SPINAL SYSTEM (K030383) [DEPUY Predicate Device AcroMed Inc.] – Additional Predicate SYNERGYTM TI INTEGR… | 2003 |
| * | K012871 | Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…Summary page 6…UY Predicate Device AcroMed Inc.] – Additional Predicate SYNERGYTM TI INTEGRAL OPEN SCREW SYSTEM (K012871) [Interpore Cross International, LLC] – Additional Predicate LDR Spine Easyspine… | 2001 |
| * | K123134 | Easyspine SystemSummary page 6…(K012871) [Interpore Cross International, LLC] – Additional Predicate LDR Spine Easyspine Posterior Spinal System (K123134) [LDR Spine USA] – Additional Predicate The 4CIS® Chiron Spinal Fixation System i… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 80 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 as stated in the FDA summary.
https://510kreport.com/device/K231655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231655: 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/K231655
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