510(k) · Cleared
ClearedSABER-C System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elevation Spine · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Sep 23, 2026 as substantially equivalent to K260660 (Elevation Spine, 2026) and 1 other predicate after a 23-day review. Its family tree reaches back 21 generations to 1984.
- Decided
- Sep 23, 2026
- Review
- 23 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K841189 (1984). 248 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- 2 generations backK250540 SABER-C SystemElevation Spine · 2025
- 1 generation backK260660 SABER-C SystemElevation Spine · 2026
- This deviceK263049 SABER-C SystemElevation Spine · 2026
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 11 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 10 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 9 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 8 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 7 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 6 generations backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- 5 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 4 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 3 generations backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- 2 generations backK250540 SABER-C SystemElevation Spine · 2025
- 1 generation backK260660 SABER-C SystemElevation Spine · 2026
- This deviceK263049 SABER-C SystemElevation Spine · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −11 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −10 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −9 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −8 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −7 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| −6 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| −5 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| −4 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| −3 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| −2 | K250540 | SABER-C System | Elevation Spine | 2025 | — |
| −1 | K260660 | SABER-C System | Elevation Spine | 2026 | — |
| 0 (this device) | K263049 | SABER-C System | Elevation Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 24 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 13 | 0 |
| 2008 | 27 | 0 |
| 2009 | 18 | 0 |
| 2010 | 10 | 0 |
| 2011 | 13 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
Planning a device in OVE? 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 |
|---|---|---|---|
| * | K260660 | SABER-C SystemSummary page 5…rvical) Panel: Orthopedic Product Code: OVE, KWQ, ODP Primary Predicate: Elevation Spine SABER-C System – K260660 Device Description: The SABER-C System is an anterior cervical interbody fusion device used to provide structural stability in… | 2026 |
| * | K192582 | NuVasive CoRoent Small Interlock SystemSummary page 6…lowing predicate devices: Primary Predicate: Elevation Spine SABER-C System (K260660) Additional Predicates: NuVasive CoRoent Small Interlock System (K192582) K263049 - Page 3 of 3 All charact… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a 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 12 months on median.
- 26 of the 248 ancestors have a recall of any class.
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. 2026, 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 Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in multiple contiguous spinal levels. 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.…
Read the full statement (281 words)
The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in
skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and
is for use in multiple contiguous spinal levels. 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 SABER-C Spacer is
to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous
bone.
The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical
plates or posterior cervical screw fixation. The SABER-C Spacer is available in a solid titanium
and a porous 3D printed titanium offering. When the SABER-C Spacer is used with the SABER-C
Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone
device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the
SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike
assembly should be used with additional supplemental fixation such as posterior cervical screw
fixation.
The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is
intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:
degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the
disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors,
deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion,
spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes
when used without the Spacer component.
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/K263049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K263049: SABER-C System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K263049
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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