510(k) Report

510(k) · Cleared

Cleared

Atlas Spine Expandable Cervical Standalone Interbody System

K192570510(k) TraditionalCleared Feb 28, 2020163-day reviewClass II21 CFR 888.3080

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

Atlas Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Feb 28, 2020 after a 163-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Feb 28, 2020
Review
163 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
0

8 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2024: 3 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared2020202220242026
  1. This deviceK192570 Atlas Spine Expandable Cervical Standalone Interbody SystemAtlas Spine, Inc. · 2020
  2. Descendant · cites it directly · 4 of its ownK222833 Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023
  3. Descendant · 2 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
  4. Descendant · 3 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
  5. Descendant · cites it directly · 0 of its ownK252822 Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc. · 2026
  6. Descendant · 4 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2021: 12023: 12024: 32025: 12026: 2
2021high 3 (2024) · low 0 (2022)2026

Most influential descendants

Showing 5 of 8 · See all
  • K222833Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023 · cites it directly4descendants
  • K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on3descendants
  • K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on2descendants
  • K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc. · 2026 · cites it directly0descendants
  • K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K192570Atlas Spine Expandable Cervical Standalone Interbody SystemAtlas Spine, Inc.2020—
+1K222833Ventana™ C Spinal SystemSpinal Elements, Inc.2023—
+2K240416Tranquil-C Interbody SystemNexus Spine, LLC2024—
+3K241467Stable-C Interbody SystemNexus Spine, LLC2024—
+1K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.2026—
+4K261279DeltaNEC Interbody SystemNexus Spine2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202310
202430
202510
202620
FIG. 1 — Lineage of K192570, 2020–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OVE? 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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234
K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.20260
K240699SCARLET® AC-TiSpineart SA20240
K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210

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, K222833 (Spinal Elements, Inc., 2023) has gone furthest, with 4 descendants of its own.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

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

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, 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
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

The Atlas Spine Expandable Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of…

Read the full statement (139 words)

The Atlas Spine Expandable Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The Atlas Spine Expandable Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The Atlas Spine Expandable Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided by the V3 Segmental Plating system and requires no additional fixation.

Indications for use as stated in the FDA 510(k) statement.

More from Atlas Spine, Inc.

16 FDA decisions under this applicant name. See the company

  • K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc. · 2026
  • K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc. · 2025
  • K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemAtlas Spine, Inc. · 2025
  • K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc. · 2024
  • K202302Atlas Spine Rebar (Ti) Spacer SystemAtlas Spine, Inc. · 2020

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K192570 · printed Nov 3, 2026

Cite this page

510(k) Report. “K192570: Atlas Spine Expandable Cervical Standalone Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192570

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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