510(k) · Cleared

Cleared

Modification to: Nuvasive Spherx II System

K083028510(k) SpecialCleared Nov 13, 200834-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 Nov 13, 2008 after a 34-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Nov 13, 2008
Review: 34 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK083028 Modification to: Nuvasive Spherx II SystemNuvasive, Inc. · 2008
Descendant · cites it directly · 1 of its ownK133287 Presson Spinal Fixation SystemNexus Spine, LLC · 2014
Descendant · 2 generations on · 0 of its ownK160820 PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016

Most influential descendants

Showing 2 of 2 · See all

K133287Presson Spinal Fixation SystemNexus Spine, LLC · 2014 · cites it directly1descendant
K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K083028	Modification to: Nuvasive Spherx II System	Nuvasive, Inc.	2008	—
+1	K133287	Presson Spinal Fixation System	Nexus Spine, LLC	2014	—
+2	K160820	PressON Pro Spinal Fixation System	Nexus Spine, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0

FIG. 1 — Lineage of K083028, 2008–2016Source: 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
*	—	SpheRx II System Named without a submission number			—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133287	Presson Spinal Fixation System	Nexus Spine, LLC	2014	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?

Of its descendants, K133287 (Nexus Spine, LLC, 2014) has gone furthest, with 1 descendant of its own.

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. 2008, 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 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 posterior 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 (231 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), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the 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/K083028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083028: Modification to: Nuvasive Spherx II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083028

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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