510(k) Report

510(k) · Cleared

Cleared

Nuvasive Oct System

K071435510(k) TraditionalCleared Aug 6, 200775-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. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Aug 6, 2007 after a 75-day review. The FDA summary names no predicate by number. 35 later devices descend from it.

Decided
Aug 6, 2007
Review
75 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

35 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2014: 2 descendants cleared2010: 1 descendant cleared2022: 4 descendants cleared2020: 3 descendants cleared2018: 3 descendants cleared2015: 2 descendants cleared2017: 3 descendants cleared2016: 4 descendants cleared2021: 2 descendants cleared2024: 3 descendants cleared2023: 2 descendants cleared2026: 4 descendants cleared20052010201520202025
  1. This deviceK071435 Nuvasive Oct SystemNuvasive, Inc. · 2007
  2. Descendant · cites it directly · 27 of its ownK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · Recalled
  3. Descendant · 2 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
  4. Descendant · 2 generations on · 13 of its ownK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
  5. Descendant · cites it directly · 10 of its ownK093319 Nuvasive Vuepoint Oct SystemNuvasive, Inc. · 2010
  6. Descendant · 2 generations on · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2010: 12014: 22015: 22016: 42017: 32018: 32019: 22020: 32021: 22022: 42023: 22024: 32026: 4
2010high 4 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 35 · See all
  • K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · cites it directly27descendants
  • K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
  • K150918PASS OCT Spinal SystemMedicrea International SA · 2015 · 2 generations on13descendants
  • K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc. · 2010 · cites it directly10descendants
  • K182182YUKON OCT Spinal SystemK2m · 2018 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071435Nuvasive Oct SystemNuvasive, Inc.2007—
+1K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.20142
+2K171444YUKON OCT Spinal SystemK2m, Inc.20173
+2K150918PASS OCT Spinal SystemMedicrea International SA2015—
+1K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.2010—
+2K182182YUKON OCT Spinal SystemK2m2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201420
201520
201640
201730
201830
201920
202030
202120
202240
202320
202430
202640
FIG. 1 — Lineage of K071435, 2007–2026Source: 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.201427
K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010
K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192

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, K133556 (Zimmer Spine, Inc., 2014) has gone furthest, with 27 descendants of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System is indicated for: (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/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial…

Read the full statement (138 words)

When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System is indicated for: (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/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The NuVasive OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors.

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 MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K071435 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071435: Nuvasive Oct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071435

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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