510(k) · Cleared

Cleared

4CIS® Chiron Spinal Fixation System

K190471510(k) TraditionalCleared Jul 24, 2019148-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Solco Biomedical Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 24, 2019 as substantially equivalent to K111136 (Depuy Spine, Inc., 2012) after a 148-day review. Its family tree reaches back 1 generation to 2012. 6 later devices descend from it.

Decided: Jul 24, 2019
Review: 148 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K111136 (2012). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK111136 Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 2012 · Recalled
This deviceK190471 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2019
Descendant · cites it directly · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
Descendant · cites it directly · 1 of its ownK203233 4CIS Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2022
Descendant · 2 generations on · 0 of its ownK250582 COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025
Descendant · 2 generations on · 0 of its ownK231655 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024
Descendant · cites it directly · 0 of its ownK240233 Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2022high 2 (2023) · low 0 (2026)2026

Most influential descendants

Showing 5 of 6 · See all

K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · cites it directly2descendants
K2032334CIS Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2022 · cites it directly1descendant
K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025 · 2 generations on0descendants
K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024 · 2 generations on0descendants
K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K111136	Expedium Spine System, Viper System, Viper 2 System	Depuy Spine, Inc.	2012	1
0 (this device)	K190471	4CIS® Chiron Spinal Fixation System	Solco Biomedical Co., Ltd.	2019	—
+1	K222229	Advanced LumFix Spinal Fixation System	CG Bio Co., Ltd.	2023	—
+1	K203233	4CIS Chiron Spinal Fixation System	Solco Biomedical Co., Ltd.	2022	—
+2	K250582	COLONNADE Posterior Screw Fixation System	CG Bio Co., Ltd.	2025	—
+2	K231655	4CIS® Chiron Spinal Fixation System	Solco Biomedical Co., Ltd.	2024	—
+1	K240233	Pitkar Spinal Pedicle Screw System	S.H.Pitkar Orthotools Pvt., Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2023	2	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K190471, 2012–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K111136	Expedium Spine System, Viper System, Viper 2 System Summary page 4 …ass Class II Regulation Number 888.3070 EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136) [DEPUY SPINE, INC.] – Primary Predicate MOSS MIAMI SPINAL SYSTEM (K030383) [DEPUY AcroMed Inc.] Pred…	Depuy Spine, Inc.	2012	1
†	K030383	Modification to Moss Miami Spinal System Polyaxial Screws	Depuyacromed	2003	—
†	K012871	Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…	Interpore Cross Intl.	2001	—

Also cleared against K111136: 14 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K222229	Advanced LumFix Spinal Fixation System	CG Bio Co., Ltd.	2023	2
K203233	4CIS Chiron Spinal Fixation System	Solco Biomedical Co., Ltd.	2022	1
K240233	Pitkar Spinal Pedicle Screw System	S.H.Pitkar Orthotools Pvt., Ltd.	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?

Its one ancestor has a recall.
Of its descendants, K222229 (CG Bio Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
14 other devices also cite its predicate K111136.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190471 · printed Nov 4, 2026

Cite this page

510(k) Report. “K190471: 4CIS® Chiron Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190471

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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