510(k) · Cleared
ClearedStalif C (R)
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 May 8, 2014 as substantially equivalent to K120819 (Centinel Spine, Inc., 2012) and 1 other predicate after a 203-day review. Its family tree reaches back 12 generations to 1984. 10 later devices descend from it.
- Decided
- May 8, 2014
- Review
- 203 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K841189 (1984). 44 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- 1 generation backK120819 Stalif CCentinel Spine, Inc. · 2012
- This deviceK133200 Stalif C (R)Centinel Spine, Inc. · 2014
- Descendant · cites it directly · 9 of its ownK151934 ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
- Descendant · 2 generations on · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · 3 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 4 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 5 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- 1 generation backK120819 Stalif CCentinel Spine, Inc. · 2012
- This deviceK133200 Stalif C (R)Centinel Spine, Inc. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015 · cites it directly9descendants
- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · 2 generations on7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on6descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 4 generations on5descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −6 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −5 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −4 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −2 | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | 1 |
| −1 | K120819 | Stalif C | Centinel Spine, Inc. | 2012 | — |
| 0 (this device) | K133200 | Stalif C (R) | Centinel Spine, Inc. | 2014 | — |
| +1 | K151934 | ROI-C Titanium-Coated Implant System | Ldr Spine USA | 2015 | — |
| +2 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +3 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +4 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +5 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K120819 | Stalif CSummary page 2…coating (ASTM F1580) on both endplates. Predicate Device: The Subject STALIF C®O intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K 120819, K072415). with respect to indications, design, function, and materials. Substantial Equivalence: Testing performed indicate tha… | 2012 |
| * | K072415 | Stalif (TM) CSummary page 2…ASTM F1580) on both endplates. Predicate Device: The Subject STALIF C®O intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K 120819, K072415). with respect to indications, design, function, and materials. Substantial Equivalence: Testing performed indicate that the STA… | 2008 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151934 | ROI-C Titanium-Coated Implant System | 2015 | 9 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 44 ancestors have a recall of any class.
- Of its descendants, K151934 (Ldr Spine USA, 2015) has gone furthest, with 9 descendants of its own.
- 10 other devices also cite its predicate K120819.
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® is 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…
Read the full statement (121 words)
The STALIF C® is 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 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 as stated in the FDA summary.
https://510kreport.com/device/K133200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133200: Stalif C (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133200
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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