510(k) · Cleared
ClearedSABER-XA System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elevation Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Aug 3, 2026 as substantially equivalent to K150135 (Medtronic Sofamor Danek USA, Inc., 2015) and 1 other predicate after a 95-day review. Its family tree reaches back 25 generations to 1984. 1 of the 456 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 3, 2026
- Review
- 95 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K841189 (1984). 455 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 456 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 backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- This deviceK261408 SABER-XA SystemElevation Spine · 2026
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 backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- This deviceK261408 SABER-XA SystemElevation Spine · 2026
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 |
|---|---|---|---|---|---|
| −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 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −1 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| 0 (this device) | K261408 | SABER-XA System | Elevation Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 22 | 0 |
| 2004 | 40 | 0 |
| 2005 | 27 | 0 |
| 2006 | 15 | 0 |
| 2007 | 20 | 0 |
| 2008 | 50 | 1 |
| 2009 | 35 | 0 |
| 2010 | 26 | 0 |
| 2011 | 34 | 0 |
| 2012 | 23 | 0 |
| 2013 | 27 | 0 |
| 2014 | 21 | 0 |
| 2015 | 20 | 0 |
| 2016 | 12 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 5…Product Code: OVD, KWQ, MAX Primary Predicate: Medtronic DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System – K150135 Device Description: The SABER-XA System is an integrated fixation lumbar interbody and anterior lumbar plate system comprised… | 2015 |
| * | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Summary page 6…mary Predicate: Medtronic DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System (K150135) Additional Predicate: Globus Medical, Inc., MAGNIFY-S Spacer (K203278) Reference Devices: Elevation Spine, SABER-C (K250240; K260660) Nvision Biomedical Technologies, Inc.,Integral… | 2021 |
| † | K250240 | Elevation Spine, SABER-C | |
| † | K260660 | SABER-C System | 2026 |
| † | K222015 | Integral Titanium Cervical Interbody | 2023 |
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 42 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 48 of the 455 ancestors have a recall of any class; 1 has a Class I recall.
- 10 other devices also cite its predicate K150135.
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. 2026, 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 Elevation Spine SABER-XA System is indicated for intervertebral fusion in patients with DDD at one or two contiguous levels from L1 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative…
Read the full statement (191 words)
The Elevation Spine SABER-XA System is indicated for intervertebral fusion in patients with DDD at one or two contiguous levels from L1 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. The SABER-XA Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The Elevation Spine SABER-XA Anterior Lumbar Plate, when used with screws and without the SABER-XA spacer component, is intended for anterior screw fixation to the lumbosacral spine (L1-S1) to treat instability resulting from: fracture (including dislocation and subluxation), tumor, degenerative disc disease (as defined above), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The Anterior Lumbar Plate is not to be used alone with Spikes, but may be used in construct with the spacer and spikes.
All interbody fusion constructs of SABER-XA System are intended to be used with FDA cleared 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/K261408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261408: SABER-XA System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261408
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026