510(k) Report

510(k) · Cleared

Cleared

Nuvasive Helix Mini Acp System

K073275510(k) SpecialCleared Jan 29, 200869-day reviewClass II21 CFR 888.3060

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

Nuvasive, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 29, 2008 after a 69-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.

Decided
Jan 29, 2008
Review
69 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

24 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2019: 3 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2024: 3 descendants cleared2016: 2 descendants cleared2014: 1 descendant cleared2023: 2 descendants cleared2025: 3 descendants cleared2018: 2 descendants cleared2022: 2 descendants cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK073275 Nuvasive Helix Mini Acp SystemNuvasive, Inc. · 2008
  2. Descendant · cites it directly · 15 of its ownK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
  3. Descendant · 2 generations on · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
  4. Descendant · 2 generations on · 6 of its ownK140234 Aspiron Acp SystemU&I Corp. · 2014
  5. Descendant · 3 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
  6. Descendant · cites it directly · 4 of its ownK191500 NuVasive® ACP SystemNu Vasive, Incorporated · 2019

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12016: 22018: 22019: 32020: 22021: 12022: 22023: 22024: 32025: 32026: 1
2011high 3 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 24 · See all
  • K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · cites it directly15descendants
  • K153526Pyrenees Cervical Plate SystemK2m · 2016 · 2 generations on6descendants
  • K140234Aspiron Acp SystemU&I Corp. · 2014 · 2 generations on6descendants
  • K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 3 generations on5descendants
  • K191500NuVasive® ACP SystemNu Vasive, Incorporated · 2019 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073275Nuvasive Helix Mini Acp SystemNuvasive, Inc.2008—
+1K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.20126
+2K153526Pyrenees Cervical Plate SystemK2m2016—
+2K140234Aspiron Acp SystemU&I Corp.2014—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.2016—
+1K191500NuVasive® ACP SystemNu Vasive, Incorporated2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
201620
201820
201930
202020
202110
202220
202320
202430
202530
202610
FIG. 1 — Lineage of K073275, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—HELIX ACP System
Named without a submission number
—

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.201215
K191500NuVasive® ACP SystemNu Vasive, Incorporated20194
K201078NuVasive® ACP SystemNu Vasive, Incorporated20203
K203253NuVasive ACP SystemNu Vasive, Incorporated20202
K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211
K103423Mis Anterior Cervical Plating SystemLife Spine20111
K190170MVP Cervical Plate SystemGS Medical Co., Ltd.20190

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, K121060 (Spinefrontier, Inc., 2012) has gone furthest, with 15 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The NuVasive HELIX Mini Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal…

Read the full statement (103 words)

The NuVasive HELIX Mini Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive HELIX Mini Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Indications for use as stated in the FDA summary.

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 KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K073275 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073275: Nuvasive Helix Mini Acp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073275

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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