510(k) Report

510(k) · Cleared

Cleared

Nuvasive Polyaxial Spinal Screws

K121619510(k) SpecialCleared Aug 24, 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

Nuvasive, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Aug 24, 2012 as substantially equivalent to K102514 (Nuvasive, Inc., 2010) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 2006. 3 later devices descend from it.

Decided
Aug 24, 2012
Review
84 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K061778 (2006). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2014: 1 descendant cleared2017: 2 descendants clearedK061778 · Nuvasive Spherx II System · Nuvasive, Inc. · 2006×2: 2 generations cleared close together, K091502 (2009), K092287 (2009) 20052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K092287 · Nuvasive Spherx II - Pedicle Screw System · Nuvasive, Inc. · 2009K091502 · Nuvasive Spherx II System · Nuvasive, Inc. · 2009K061778 · Nuvasive Spherx II System · Nuvasive, Inc. · 20060
  1. Root · 3 generations backK061778 Nuvasive Spherx II SystemNuvasive, Inc. · 2006
  2. 2 generations backK091502 Nuvasive Spherx II SystemNuvasive, Inc. · 2009
  3. 1 generation backK092287 Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009
  4. This deviceK121619 Nuvasive Polyaxial Spinal ScrewsNuvasive, Inc. · 2012
  5. Descendant · cites it directly · 1 of its ownK142737 MAS PLIF Fixation systemNu Vasive, Incorporated · 2014
  6. Descendant · 2 generations on · 0 of its ownK172469 TiLock Modular Spinal SystemGenesys Spine · 2017
  7. Descendant · cites it directly · 0 of its ownK171894 NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K142737MAS PLIF Fixation systemNu Vasive, Incorporated · 2014 · cites it directly1descendant
  • K172469TiLock Modular Spinal SystemGenesys Spine · 2017 · 2 generations on0descendants
  • K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K061778Nuvasive Spherx II SystemNuvasive, Inc.2006—
−2K091502Nuvasive Spherx II SystemNuvasive, Inc.2009—
−1K092287Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc.2009—
0 (this device)K121619Nuvasive Polyaxial Spinal ScrewsNuvasive, Inc.2012—
+1K142737MAS PLIF Fixation systemNu Vasive, Incorporated2014—
+2K172469TiLock Modular Spinal SystemGenesys Spine2017—
+1K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201720
FIG. 1 — Lineage of K121619, 2006–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K102514Nuvasive Spherx II -Mas Deformity Spinal System
Summary page 1
…TM The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the Precept (K1025 14), Armada® (K092287), and SplzeRx® PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. D.…
Nuvasive, Inc.2010—
*K092287Nuvasive Spherx II - Pedicle Screw System
Summary page 1
…TM The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the Precept (K1025 14), Armada® (K092287), and SplzeRx® PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. D. Device Description…
Nuvasive, Inc.2009—
*K090981Modification to: Nuvasive Spherx System
Summary page 1
…TM The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the Precept (K1025 14), Armada® (K092287), and SplzeRx® PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. D. Device Description The NuVasive Polyaxia…
Nuvasive, Inc.2009—

Also cleared against K102514: 7 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141
K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170

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 6 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K142737 (Nu Vasive, Incorporated, 2014) has gone furthest, with 1 descendant of its own.
  • 7 other devices also cite its predicate K102514.

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

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
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

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

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 (692 words)

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 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 Systemis 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 (L_3 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

When used as a pedicle screw fixation system, the NuVasive Armada 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 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 Armada 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 Armada 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. Pseudloarthosis

7. Tumor resection and/or

8. Failed previous fusion

When used as a pedlicle screw fixation system, the NuVasive Precept 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 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 Precept 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 Precept 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. Pseudloarthosis

7. Tumor resection and/or

6. Failed previous fusion

Indications for use as stated in the FDA summary.

Also cleared against K102514

7 other devices cite the same predicate.

  • K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated · 2017
  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015
  • K142737MAS PLIF Fixation systemNu Vasive, Incorporated · 2014
  • K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
  • K122352Nuvasive Precept Spinal SystemNuvasive, Inc. · 2012

More from Nuvasive, Inc.

117 FDA decisions under this applicant name. See the company

  • P200022/S016Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S017Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S012Simplify DiscNuvasive, Inc. · 2025
  • P200022/S015Simplify Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S014Simplify Cervical Artificial DiscNuvasive, Inc. · 2024

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K121619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121619: Nuvasive Polyaxial Spinal Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121619

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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