510(k) · Cleared
ClearedStalif Cti, Stalif C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centinel Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Oct 24, 2014 as substantially equivalent to K130177 (Medtronic Sofamor Danek USA, Inc., 2013) after an 85-day review. Its family tree reaches back 1 generation to 2013. 276 later devices descend from it.
- Decided
- Oct 24, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130177 (2013). 276 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK130177 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK142079 Stalif Cti, Stalif CCentinel Spine, Inc. · 2014
- Descendant · cites it directly · 273 of its ownK150053 STALIF C; STALIF C-TiCentinel Spine, Inc. · 2015
- Descendant · 2 generations on · 152 of its ownK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 145 of its ownK152532 AERO -C Cervical Cage SystemStryker Spine · 2015
- Descendant · 3 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 2 generations on · 108 of its ownK152515 TOMCAT Cervical Spinal SystemChoicespine, LP · 2015
Showing 5 of 276 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 276 · See all- K150053STALIF C; STALIF C-TiCentinel Spine, Inc. · 2015 · cites it directly273descendants
- K151939COALITION SpacersGlobus Medical, Inc. · 2016 · 2 generations on152descendants
- K152532AERO -C Cervical Cage SystemStryker Spine · 2015 · 2 generations on145descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 3 generations on129descendants
- K152515TOMCAT Cervical Spinal SystemChoicespine, LP · 2015 · 2 generations on108descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130177 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K142079 | Stalif Cti, Stalif C | Centinel Spine, Inc. | 2014 | — |
| +1 | K150053 | STALIF C; STALIF C-Ti | Centinel Spine, Inc. | 2015 | — |
| +2 | K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 | — |
| +2 | K152532 | AERO -C Cervical Cage System | Stryker Spine | 2015 | — |
| +3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +2 | K152515 | TOMCAT Cervical Spinal System | Choicespine, LP | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 19 | 0 |
| 2021 | 24 | 0 |
| 2022 | 30 | 0 |
| 2023 | 41 | 0 |
| 2024 | 39 | 0 |
| 2025 | 45 | 0 |
| 2026 | 40 | 0 |
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 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 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130177 | Anatomic Peek Cervical Fusion SystemSummary page 5…icate Device: The subject STALIF C® and STALIF C® Ti intervertebral body fusion devices are substantially equivalent to predicate ANATOMIC PEEKTM CERVICAL FUSION SYSTEM (K130177) with respect to indications, design, function, and materials. Substantial Equivalence: STALIF C®, STALIF C® Ti and predicate AN… | 2013 |
What descends from it? (276)
See all 2765 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (141 words)
The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® and STALIF C® Ti are intended to be used at one level.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142079: Stalif Cti, Stalif C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142079
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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