510(k) · Cleared
ClearedTotalTi ACDF by SAGICO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Analytics & Geometrical Implant Co, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Nov 21, 2023 as substantially equivalent to K221138 (Sagico VA USA, LLC, 2023) and 3 other predicates after a 54-day review. Its family tree reaches back 23 generations to 1984. 1 of the 224 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 21, 2023
- Review
- 54 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 23 generations to K841189 (1984). 223 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 224 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- 2 generations backK180401 TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC · 2018
- 1 generation backK221138 Titus Titanium Cervical by SAGICOSagico VA USA, LLC · 2023
- This deviceK233191 TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC · 2023
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 3 generations backK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- 2 generations backK180401 TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC · 2018
- 1 generation backK221138 Titus Titanium Cervical by SAGICOSagico VA USA, LLC · 2023
- This deviceK233191 TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC · 2023
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −3 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | 2017 | — |
| −2 | K180401 | TiWAVE-C™ Porous Titanium Cervical Cage | Kalitec Direct, LLC | 2018 | — |
| −1 | K221138 | Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC | 2023 | — |
| 0 (this device) | K233191 | TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 20 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 12 | 0 |
| 2008 | 34 | 1 |
| 2009 | 21 | 0 |
| 2010 | 10 | 0 |
| 2011 | 17 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K221138 | Titus Titanium Cervical by SAGICOSummary page 5…e Name Product Code Number PRIMARY PREDICATE TITUS TITANIUM SAGICO VA USA, LLC OVE K221138 CERVICAL BY SAGICO __________________ ____________________ _________________ _____________… | 2023 |
| * | K161710 | Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSummary page 5…________________ _________________ ________________ Additional Predicates Spinal Analytics & OVE K161710 SAGICO IBF System Geometrical Implant Co, LLC (dba/ SAGICO)… | 2017 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 5…F System Geometrical Implant Co, LLC (dba/ SAGICO) OVE K091088 LDR Spine LDR Spine Cervical Interbody Fusion System… | 2009 |
| * | K180401 | TiWAVE-C™ Porous Titanium Cervical CageSummary page 5…LDR Spine LDR Spine Cervical Interbody Fusion System OVE K180401 TiWAVE-C Porous Kalitec Direct, LLC Titanium Cervical Cage… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 17 companies; a new generation was cleared every 10 months on median.
- 26 of the 223 ancestors have a recall of any class; 1 has a Class I recall.
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. 2023, 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 TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The…
Read the full statement (130 words)
The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233191 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233191: TotalTi ACDF by SAGICO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233191
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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