510(k) · Cleared

Cleared

Nanovis Spinal System

K113173510(k) TraditionalCleared Jan 19, 201284-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

Nanovis, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 19, 2012 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 7 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.

Decided: Jan 19, 2012
Review: 84 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 8

Its longest line of descent runs back 4 generations to K901587 (1990). 28 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
This deviceK113173 Nanovis Spinal SystemNanovis, LLC · 2012
Descendant · cites it directly · 1 of its ownK193211 Nano FortiFix® SystemNanovis Spine, LLC · 2020
Descendant · cites it directly · 0 of its ownK203452 Nano FortiFix® SystemNanovis, LLC · 2020

Most influential descendants

Showing 2 of 2 · See all

K193211Nano FortiFix® SystemNanovis Spine, LLC · 2020 · cites it directly1descendant
K203452Nano FortiFix® SystemNanovis, LLC · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K901587	TSRH Sacral L-Connector	Danek Medical, Inc.	1990	—
−3	K950099	Synergy (TM) TI Posterior Spinal System	Buckman Co., Inc.	1997	—
−2	K973836	Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…	Cross Medical Products, Inc.	1998	—
−1	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…	Cross Medical Products, Inc.	1998	—
0 (this device)	K113173	Nanovis Spinal System	Nanovis, LLC	2012	—
+1	K193211	Nano FortiFix® System	Nanovis Spine, LLC	2020	—
+1	K203452	Nano FortiFix® System	Nanovis, LLC	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	5	0
1993	2	0
1994	2	0
1995	2	0
1996	1	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	2	0

FIG. 1 — Lineage of K113173, 1990–2020Source: 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? (8)

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
*	K031655	CD Horizon Spinal System Summary page 1 …s Spinal System components are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460), Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168…	Medtronic Sofamor Danek USA, Inc.	2003	1
*	K041460	CD Horizon Spinal System Summary page 1 …System components are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460), Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623…	Medtronic Sofamor Danek USA, Inc.	2004	—
*	K041119	Expedium Spine System Summary page 1 …tanium alloy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460), Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749).…	Depuy Spine, Inc.	2004	—
*	K051024	Expedium Spine System Summary page 1 …loy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: CD HORIZON® (K031655/K041460), Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749).…	Depuy Spine, Inc.	2005	—
*	K992168	Moss Miami 6.35MM Polyaxial Screw Summary page 1 …6. Predicate Devices: CD HORIZON® (K031655/K041460), Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749).…	Depuyacromed	1999	—
*	K022623	5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) Summary page 1 …cate Devices: CD HORIZON® (K031655/K041460), Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749).…	Depuyacromed	2002	—
*	K950099	Synergy (TM) TI Posterior Spinal System Summary page 1 …Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749). ~ ~JL Page 5…	Buckman Co., Inc.	1997	—
*	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior… Summary page 1 …Expedium Tm 5.5 Ti Spine System (K041 119/K051024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749). ~ ~JL Page 5…	Cross Medical Products, Inc.	1998	—

Also cleared against K031655: 24 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K193211	Nano FortiFix® System	Nanovis Spine, LLC	2020	1
K203452	Nano FortiFix® System	Nanovis, LLC	2020	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 22 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
1 of the 28 ancestors has a recall of any class.
Of its descendants, K193211 (Nanovis Spine, LLC, 2020) has gone furthest, with 1 descendant of its own.
24 other devices also cite its predicate K031655.

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. 2012, 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 Nanovis Spinal System is intended for posterior, non-cervical (i.e., Ti-Si) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DOD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113173: Nanovis Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113173

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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