510(k) · Cleared

Cleared

Nuvasive Spherx II System

K091502510(k) SpecialCleared Jul 22, 200962-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

Nuvasive, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 22, 2009 as substantially equivalent to K061778 (Nuvasive, Inc., 2006) after a 62-day review. Its family tree reaches back 1 generation to 2006. 153 later devices descend from it.

Decided: Jul 22, 2009
Review: 62 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K061778 (2006). 153 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK061778 Nuvasive Spherx II SystemNuvasive, Inc. · 2006
This deviceK091502 Nuvasive Spherx II SystemNuvasive, Inc. · 2009
Descendant · cites it directly · 82 of its ownK132014 GSB Global Spinal Balance SystemNuvasive, Inc. · 2013
Descendant · 2 generations on · 78 of its ownK142499 Reline SystemNu Vasive, Incorporated · 2014
Descendant · cites it directly · 77 of its ownK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
Descendant · cites it directly · 72 of its ownK092287 Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009
Descendant · 2 generations on · 67 of its ownK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

2009high 23 (2023) · low 1 (2009)2026

Most influential descendants

Showing 5 of 153 · See all

K132014GSB Global Spinal Balance SystemNuvasive, Inc. · 2013 · cites it directly82descendants
K142499Reline SystemNu Vasive, Incorporated · 2014 · 2 generations on78descendants
K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015 · cites it directly77descendants
K092287Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009 · cites it directly72descendants
K160989NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 2 generations on67descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K061778	Nuvasive Spherx II System	Nuvasive, Inc.	2006	—
0 (this device)	K091502	Nuvasive Spherx II System	Nuvasive, Inc.	2009	—
+1	K132014	GSB Global Spinal Balance System	Nuvasive, Inc.	2013	—
+2	K142499	Reline System	Nu Vasive, Incorporated	2014	—
+1	K143684	NuVasive Reline System	Nu Vasive, Incorporated	2015	—
+1	K092287	Nuvasive Spherx II - Pedicle Screw System	Nuvasive, Inc.	2009	—
+2	K160989	NuVasive® Reline® System	Nu Vasive, Incorporated	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	2	0
2012	3	0
2013	5	0
2014	7	0
2015	8	0
2016	10	0
2017	6	0
2018	11	0
2019	6	0
2020	9	0
2021	10	0
2022	9	0
2023	23	0
2024	15	0
2025	12	0
2026	14	0

FIG. 1 — Lineage of K091502, 2006–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K061778	Nuvasive Spherx II System Summary page 1 …NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject SpheRx II -Pedicle Screw System is substantially equivalent to the SpheRx II System (K061778) currently distributed commercially in the U.S. by NuVasive. D. Device Description The Nu Vasive SpheRx II -Pedicle Sc…	Nuvasive, Inc.	2006	—

Also cleared against K061778: 2 other devices →

What descends from it? (153)

See all 153

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

Number	Device	Applicant	Decided	Descendants
K132014	GSB Global Spinal Balance System	Nuvasive, Inc.	2013	82
K143684	NuVasive Reline System	Nu Vasive, Incorporated	2015	77
K092287	Nuvasive Spherx II - Pedicle Screw System	Nuvasive, Inc.	2009	72
K102514	Nuvasive Spherx II -Mas Deformity Spinal System	Nuvasive, Inc.	2010	13
K111410	Nuvasive Long Lateral Spinal System	Nuvasive, Inc.	2011	1

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 no recall.
Of its descendants, K132014 (Nuvasive, Inc., 2013) has gone furthest, with 82 descendants of its own.
2 other devices also cite its predicate K061778.

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. 2009, 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?

When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended 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 posteriorto thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed…

Read the full statement (229 words)

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

2. Degenerative spondylolisthesis with objective evidence of neurologic impairment

3. Fracture

4. Dislocation

5. Scoliosis

6. Kyphosis

7. Spinal tumor and/or

8. Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), removal of the implants after attainment of a solid fusion. with

When used as an anterolateral non-pedicle screw system inthe thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

2. Spinal stenosis

3. Spondylolisthesis

4. Spinal deformities

5. Fracture

6. Pseudoarthosis

7. Tumor resection and/or

8. Failed previous fusion

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091502 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091502: Nuvasive Spherx II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091502

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