510(k) · Cleared
ClearedStabilis SA Cervical Stand-Alone System (Various PNs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuity Surgical Devices, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jul 30, 2025 as substantially equivalent to K230639 (Acuity Surgical Devices, LLC, 2023) and 3 other predicates after a 54-day review. Its family tree reaches back 26 generations to 1984. 1 of the 608 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 30, 2025
- Review
- 54 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 26 generations to K841189 (1984). 606 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 608 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- 2 generations backK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- 1 generation backK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
- This deviceK251735 Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025
- Descendant · cites it directly · 0 of its ownK254130 C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 8 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 7 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 6 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 5 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 4 generations backK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- 3 generations backK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- 2 generations backK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- 1 generation backK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
- This deviceK251735 Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −8 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −7 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −6 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −5 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| −4 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| −3 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| −2 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| −1 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | — |
| 0 (this device) | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | — |
| +1 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 8 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 15 | 0 |
| 2001 | 20 | 0 |
| 2002 | 17 | 0 |
| 2003 | 25 | 0 |
| 2004 | 36 | 0 |
| 2005 | 30 | 0 |
| 2006 | 23 | 0 |
| 2007 | 26 | 0 |
| 2008 | 61 | 1 |
| 2009 | 41 | 0 |
| 2010 | 27 | 0 |
| 2011 | 41 | 0 |
| 2012 | 28 | 0 |
| 2013 | 31 | 0 |
| 2014 | 33 | 0 |
| 2015 | 19 | 0 |
| 2016 | 21 | 0 |
| 2017 | 15 | 0 |
| 2018 | 9 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K230639 | Align Cervical Interbody Fusion SystemSummary page 5…s 510(k) Number Product Code Trade Name Manufacturer Primary Predicate Device Align Cervical Interbody K230639 ODP Acuity Surgical Devices LLC Fusion D… | 2023 |
| * | K211417 | F3D-C2 Cervical Stand-Alone SystemSummary page 5…Acuity Surgical Devices LLC Fusion Device Addi onal Predicate Devices F3D-C2 Cervical Stand- K211417 OVE CoreLink, LLC Alone System… | 2022 |
| * | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemSummary page 5…OVE CoreLink, LLC Alone System NEXXT MATRIXX Stand K200543 OVE Alone Cervical-Turn Lock Nexxt Spine, LLC (-TL) System… | 2020 |
| * | K111272 | Rhausler Plage Anterior Cervical Fusion SystemSummary page 5…Alone Cervical-Turn Lock Nexxt Spine, LLC (-TL) System Rhausler Plage Anterior K111272 ODP Rhausler Inc Cervical Fusion System… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254130 | C.A. Medical Interbody Fusion System | 2026 | 0 |
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 41 years and passes through 18 companies; a new generation was cleared every 10 months on median.
- 70 of the 606 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K254130 (C.A. Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
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. 2025, 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 Stabilis SA Cervical Stand-Alone System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Stabilis SA Cervical Stand-Alone System is…
Read the full statement (357 words)
The Stabilis SA Cervical Stand-Alone System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.
The Stabilis SA Cervical Stand-Alone System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Stabilis SA Cervical Stand-Alone System cages may be used as a stand-alone device when two (2) vertebral body bone screws are used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may be used as a stand-alone device when at least two (2) vertebral body bone screws are utilized with one inferior and one superior screw trajectory on opposite sides of the cage. If the physician chooses to use Stabilis SA Cervical Stand-Alone System cages with fewer than two (2) screws, then an additional supplemental spinal fixation system cleared for use in the cervical spine must be used.
Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may only be used at contiguous levels if at least two (2) vertebral body bone screws are utilized in each cage with one inferior and one superior screw trajectory on opposite sides of the cage, such that no more than two (2) vertebral body bone screws are implanted at the shared vertebral body with one inferior and one superior screw trajectory on opposite sides of the cages. Additionally, a cage with four (4) screw holes and a cage with two (2) screw holes can be implanted contiguously only if the cage with four (4) screw holes uses at least (2) vertebral body bone screws with one inferior screw on the left side of the cage and one superior screw on the right side 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/K251735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251735: Stabilis SA Cervical Stand-Alone System (Various PNs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251735
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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