510(k) · Cleared
ClearedStalif (TM) C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicraft, Ltd. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 25, 2008 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 2 other predicates after a 150-day review. Its family tree reaches back 1 generation to 2001. 1 of the 952 devices in its family, counting itself, has a Class I recall. 948 later devices descend from it.
- Decided
- Jan 25, 2008
- Review
- 150 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to P980048 (2001). 3 ancestors in all. 948 later devices descend from it, 13 citing it directly. 1 of the 952 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- This deviceK072415 Stalif (TM) CSurgicraft, Ltd. · 2008
- Descendant · cites it directly · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · 2 generations on · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · 2 generations on · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 2 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
Showing 5 of 948 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 948 · See all- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · cites it directly907descendants
- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · 2 generations on834descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · 2 generations on753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 2 generations on696descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| 0 (this device) | K072415 | Stalif (TM) C | Surgicraft, Ltd. | 2008 | — |
| +1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 20 | 0 |
| 2015 | 37 | 0 |
| 2016 | 55 | 0 |
| 2017 | 69 | 0 |
| 2018 | 71 | 0 |
| 2019 | 79 | 0 |
| 2020 | 94 | 0 |
| 2021 | 75 | 1 |
| 2022 | 76 | 0 |
| 2023 | 92 | 0 |
| 2024 | 94 | 0 |
| 2025 | 79 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions: e P980048 S003 BAK/C Vista Cervical Interbody Fusion Device, Zimmer Spine, USA * P000028 AFFINITY Anterior Cervical Cage System, Medtronic… | 2001 |
| * | P000028 | Affinity (TM) Cage SystemSummary page 1…sition when compared to the predicate devices cleared under the following submissions: e P980048 S003 BAK/C Vista Cervical Interbody Fusion Device, Zimmer Spine, USA * P000028 AFFINITY Anterior Cervical Cage System, Medtronic Sofamor Danek, USA » K071833 Mosaic Device (a PEEK Cervical IBF device), Spina… | 2002 |
| * | K071833 | Mosaic Devices Cleared while this submission was under review Summary page 1…sions: e P980048 S003 BAK/C Vista Cervical Interbody Fusion Device, Zimmer Spine, USA * P000028 AFFINITY Anterior Cervical Cage System, Medtronic Sofamor Danek, USA » K071833 Mosaic Device (a PEEK Cervical IBF device), Spinal Elements, Inc. Surgicraft Limited / 16 The Oaks / Clews Road / Reddilch : Wor… | 2007 |
What descends from it? (948)
See all 94813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073109 | Stalif TT Intervertebral Body Fusion System | 2008 | 907 |
| K102606 | Avs Anchor-C Cervical Cage System | 2011 | 384 |
| K111439 | Chesapeake (Cervical Components) | 2011 | 345 |
| K133494 | Chesapeake Spinal System | 2014 | 330 |
| K120819 | Stalif C | 2012 | 206 |
| K102547 | Coroent Interlock System | 2011 | 131 |
| K142940 | Endoskeleton TCS System | 2015 | 111 |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | 2016 | 32 |
| K133200 | Stalif C (R) | 2014 | 10 |
| K130274 | Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System | 2013 | 9 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 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. 2008, 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 is intended to be used as an. intervertebral body fusion cage as a stand alone system used with the 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 Tl 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…
Read the full statement (123 words)
The STALIF C is intended to be used as an. intervertebral body fusion cage as a stand alone system used with the 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 Tl 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 to facilitate fusion. STALIF™ C is 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/K072415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072415: Stalif (TM) C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072415
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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