510(k) · Cleared
ClearedSTALIF C; STALIF C-Ti
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 Jun 24, 2015 as substantially equivalent to K142079 (Centinel Spine, Inc., 2014) after a 163-day review. Its family tree reaches back 2 generations to 2013. 273 later devices descend from it.
- Decided
- Jun 24, 2015
- Review
- 163 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K130177 (2013). 273 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK130177 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK142079 Stalif Cti, Stalif CCentinel Spine, Inc. · 2014
- This deviceK150053 STALIF C; STALIF C-TiCentinel Spine, Inc. · 2015
- Descendant · cites it directly · 152 of its ownK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 145 of its ownK152532 AERO -C Cervical Cage SystemStryker Spine · 2015
- Descendant · 2 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · cites it directly · 108 of its ownK152515 TOMCAT Cervical Spinal SystemChoicespine, LP · 2015
- Descendant · 3 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
Showing 5 of 273 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 273 · See all- K151939COALITION SpacersGlobus Medical, Inc. · 2016 · cites it directly152descendants
- K152532AERO -C Cervical Cage SystemStryker Spine · 2015 · cites it directly145descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 2 generations on129descendants
- K152515TOMCAT Cervical Spinal SystemChoicespine, LP · 2015 · cites it directly108descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 3 generations on106descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K130177 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K142079 | Stalif Cti, Stalif C | Centinel Spine, Inc. | 2014 | — |
| 0 (this device) | K150053 | STALIF C; STALIF C-Ti | Centinel Spine, Inc. | 2015 | — |
| +1 | K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K152532 | AERO -C Cervical Cage System | Stryker Spine | 2015 | — |
| +2 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +1 | K152515 | TOMCAT Cervical Spinal System | Choicespine, LP | 2015 | — |
| +3 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 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 |
|---|---|---|---|
| * | K142079 | Stalif Cti, Stalif CSummary page 3…1331 H Street NW, 12" Floor Washington, DC 20005 Phone: (202) 552-5800 [email protected] June 22, 2015 21 CFR §888.3080, Intervertebral body fusion device 11 OVE K142079, STALIF C®, STALIF C-Ti™ K 142264, Amedica Valeo® Cage K150053 Page 1 of 2 The STALIF C® and STALIF C-Ti™ devices are intended… | 2014 |
| † | K142264 | Valeo C Spacer System, Valeo II C IBF Device | 2014 |
What descends from it? (273)
See all 2739 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151939 | COALITION Spacers | 2016 | 152 |
| K152532 | AERO -C Cervical Cage System | 2015 | 145 |
| K152515 | TOMCAT Cervical Spinal System | 2015 | 108 |
| K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System | 2016 | 46 |
| K192582 | NuVasive CoRoent Small Interlock System | 2019 | 30 |
| K173077 | Cavetto-SA Cervical Cage System | 2018 | 21 |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX… | 2018 | 12 |
| K181621 | Stable-C Interbody System | 2018 | 7 |
| K163474 | CAVUX CervicalCage-L SA System | 2017 | 0 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151939 (Globus Medical, Inc., 2016) has gone furthest, with 152 descendants of its own.
- 4 other devices also cite its predicate K142079.
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. 2015, 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 at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin…
Read the full statement (137 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 at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space 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.
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/K150053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150053: STALIF C; STALIF C-Ti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150053
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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