510(k) · Cleared
ClearedAxTiHA® Stand-Alone ALIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 24, 2025 as substantially equivalent to K212967 (Innovasis, Inc., 2021) and 1 other predicate after a 24-day review. Its family tree reaches back 25 generations to 1984. 1 of the 283 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 24, 2025
- Review
- 24 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K841189 (1984). 282 ancestors in all. No later device cites it as a predicate yet. 1 of the 283 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- 2 generations backK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
- 1 generation backK212967 AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2021
- This deviceK250603 AxTiHA® Stand-Alone ALIF SystemInnovasis · 2025
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc. · 2018 · Recalled
- 3 generations backK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- 2 generations backK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
- 1 generation backK212967 AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2021
- This deviceK250603 AxTiHA® Stand-Alone ALIF SystemInnovasis · 2025
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. | 2018 | 1 |
| −3 | K183064 | TxTi IBF System | Innovasis, Inc. | 2019 | 1 |
| −2 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 | 1 |
| −1 | K212967 | AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2021 | — |
| 0 (this device) | K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 23 | 0 |
| 2005 | 18 | 0 |
| 2006 | 8 | 0 |
| 2007 | 13 | 0 |
| 2008 | 39 | 1 |
| 2009 | 23 | 0 |
| 2010 | 18 | 0 |
| 2011 | 17 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 13 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2019 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K212967 | AxTiHA Stand-Alone ALIF SystemSummary page 5…888.3080 Product Code(s) OovD | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212967 AxTIHA® Stand-Alone ALIF System OoVvD K160605 MectaLIF Anterior Stand-Alone OovD Device Description Summary 21 CFR 807.92(a)(4)… | 2021 |
| * | K160605 | MectaLIF Anterior Stand-AloneSummary page 5…ted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212967 AxTIHA® Stand-Alone ALIF System OoVvD K160605 MectaLIF Anterior Stand-Alone OovD Device Description Summary 21 CFR 807.92(a)(4) The AxTiHA system is for Anterior Lumbar Inter… | 2016 |
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 36 of the 282 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Innovasis AxTiHA Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may…
Read the full statement (185 words)
The Innovasis AxTiHA Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
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/K250603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250603: AxTiHA® Stand-Alone ALIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250603
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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