510(k) · Cleared
ClearedTOMCAT Cervical Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 18, 2015 as substantially equivalent to K102606 (Stryker Spine, 2011) and 4 other predicates after a 107-day review. Its family tree reaches back 11 generations to 1984. 108 later devices descend from it.
- Decided
- Dec 18, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 59 ancestors in all. 108 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- This deviceK152515 TOMCAT Cervical Spinal SystemChoicespine, LP · 2015
- Descendant · cites it directly · 103 of its ownK170953 Tomcat Cervical Spinal SystemChoicespine, LP · 2017
- Descendant · 2 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 3 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 2 generations on · 39 of its ownK171489 Acapella Cervical Spacer SystemChoicespine, LP · 2017
- Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- This deviceK152515 TOMCAT Cervical Spinal SystemChoicespine, LP · 2015
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K170953Tomcat Cervical Spinal SystemChoicespine, LP · 2017 · cites it directly103descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 2 generations on67descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 3 generations on59descendants
- K171489Acapella Cervical Spacer SystemChoicespine, LP · 2017 · 2 generations on39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | 1 |
| 0 (this device) | K152515 | TOMCAT Cervical Spinal System | Choicespine, LP | 2015 | — |
| +1 | K170953 | Tomcat Cervical Spinal System | Choicespine, LP | 2017 | — |
| +2 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +3 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +2 | K171489 | Acapella Cervical Spacer System | Choicespine, LP | 2017 | — |
| +3 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 11 | 0 |
| 2023 | 18 | 0 |
| 2024 | 21 | 0 |
| 2025 | 23 | 0 |
| 2026 | 21 | 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? (5)
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 |
|---|---|---|---|
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 4…stem. This device is to be used in patients who have had six weeks of non-operative treatment. Predicate Device(s): The primary predicate is AVS Anchor-C, Stryker Inc., K102606. Other predicates are: Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device, SpineFrontier Inc., K142026 SpineSmith IN: C2… | 2011 |
| * | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSummary page 4…(s): The primary predicate is AVS Anchor-C, Stryker Inc., K102606. Other predicates are: Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device, SpineFrontier Inc., K142026 SpineSmith IN: C2 Spinal Fixation System, SpineSmith Partners LLP, K122630 STALIF C® & STALIF-C Ti™, Centinel Spine, Inc., K15005… | 2014 |
| * | K122630 | IN:C2 Spinal Fixation SystemSummary page 4…edicates are: Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device, SpineFrontier Inc., K142026 SpineSmith IN: C2 Spinal Fixation System, SpineSmith Partners LLP, K122630 STALIF C® & STALIF-C Ti™, Centinel Spine, Inc., K150053 BAK/Cervical Interbody System, Centerpulse Spine, PMA# P980048 === Page… | 2012 |
| * | K150053 | STALIF C; STALIF C-TiSummary page 4…ody Fusion Device, SpineFrontier Inc., K142026 SpineSmith IN: C2 Spinal Fixation System, SpineSmith Partners LLP, K122630 STALIF C® & STALIF-C Ti™, Centinel Spine, Inc., K150053 BAK/Cervical Interbody System, Centerpulse Spine, PMA# P980048… | 2015 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 4…2 Spinal Fixation System, SpineSmith Partners LLP, K122630 STALIF C® & STALIF-C Ti™, Centinel Spine, Inc., K150053 BAK/Cervical Interbody System, Centerpulse Spine, PMA# P980048 K152515… | 2001 |
What descends from it? (108)
See all 1083 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?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 59 ancestors have a recall of any class.
- Of its descendants, K170953 (Choicespine, LP, 2017) has gone furthest, with 103 descendants of its own.
- 16 other devices also cite its predicate K102606.
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 TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one level from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative…
Read the full statement (151 words)
The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one level from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or 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 device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152515: TOMCAT Cervical Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152515
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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