510(k) · Cleared
ClearedSureMAX-SA Cervical Standalone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Implants, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jul 16, 2021 as substantially equivalent to K151939 (Globus Medical, Inc., 2016) and 1 other predicate after a 93-day review. Its family tree reaches back 23 generations to 1984. 1 of the 332 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Jul 16, 2021
- Review
- 93 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K841189 (1984). 323 ancestors in all, the oldest K792352 (1979). 8 later devices descend from it, 3 citing it directly. 1 of the 332 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 backK171140 Matrixx SystemNexxt Spine, LLC · 2017
- 2 generations backK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- 1 generation backK193000 Hexanium® ACIFSpinevision, S.A.S. · 2020
- This deviceK211111 SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 3 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · 5 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
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 backK171140 Matrixx SystemNexxt Spine, LLC · 2017
- 2 generations backK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- 1 generation backK193000 Hexanium® ACIFSpinevision, S.A.S. · 2020
- This deviceK211111 SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · cites it directly5descendants
- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 2 generations on3descendants
- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 3 generations on2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 4 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 5 generations on0descendants
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 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
| −2 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| −1 | K193000 | Hexanium® ACIF | Spinevision, S.A.S. | 2020 | — |
| 0 (this device) | K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | 2021 | — |
| +1 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +2 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +3 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +4 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +5 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 16 | 0 |
| 2004 | 25 | 0 |
| 2005 | 19 | 0 |
| 2006 | 10 | 0 |
| 2007 | 16 | 0 |
| 2008 | 45 | 1 |
| 2009 | 28 | 0 |
| 2010 | 17 | 0 |
| 2011 | 26 | 0 |
| 2012 | 16 | 0 |
| 2013 | 15 | 0 |
| 2014 | 17 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
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? (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 |
|---|---|---|---|
| * | K151939 | COALITION SpacersSummary page 4…bcomponents are manufactured from Ti- 6Al-4V ELI titanium alloy per F136. Primary Predicate: COALITION MIS™ Spacer, Globus Medical, Inc. – K151939 Additional Predicate: Hexanium® ACIF, SpineVision SAS – K193000… | 2016 |
| * | K193000 | Hexanium® ACIFSummary page 4…4V ELI titanium alloy per F136. Primary Predicate: COALITION MIS™ Spacer, Globus Medical, Inc. – K151939 Additional Predicate: Hexanium® ACIF, SpineVision SAS – K193000 K211111- Page 2 of 2 Performanc… | 2020 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 39 of the 323 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223105 (Kyocera Medical Technologies, Inc., 2022) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K151939.
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. 2021, 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 SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with the device. The…
Read the full statement (152 words)
The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level and with supplemental fixation.
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/K211111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211111: SureMAX-SA Cervical Standalone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211111
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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