510(k) · Cleared
ClearedDOLOMITE Anterior Cervical Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Oct 26, 2020 as substantially equivalent to K160154 (Astura Medical, 2016) and 3 other predicates after a 91-day review. Its family tree reaches back 19 generations to 1984. 3 later devices descend from it.
- Decided
- Oct 26, 2020
- Review
- 91 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 245 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 2 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- This deviceK202065 DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC · 2020
- Descendant · cites it directly · 0 of its ownK242517 ProAM ACDF SystemPro Surgical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223837 SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023
- Descendant · cites it directly · 0 of its ownK210382 Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 6 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 5 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 4 generations backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- 3 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 2 generations backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- 1 generation backK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- This deviceK202065 DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −6 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −5 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| −3 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| −2 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| −1 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| 0 (this device) | K202065 | DOLOMITE Anterior Cervical Stabilization System | Astura Medical, LLC | 2020 | — |
| +1 | K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024 | — |
| +1 | K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | 2023 | — |
| +1 | K210382 | Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC | 2021 | — |
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 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
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? (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 |
|---|---|---|---|
| * | K160154 | ALTA Anterior Cervical Interbody SpacerSummary page 4…OVE, ODP CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) Device Secondary Predicate Globus COALITION Spacer (K173115); Globus HEDRON Cervical Spacer Device (K191243);… | 2016 |
| * | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Summary page 4…Panel Orthopedic Primary Predicate Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) Device Secondary Predicate Globus COALITION Spacer (K173115); Globus HEDRON Cervical Spacer Device (K191243); LDR Spine Cervical Interbody Fusion System (K091088) Device Des… | 2017 |
| * | K191243 | HEDRON Cervical SpacersSummary page 4…ALTA Anterior Cervical Interbody Spacer (K160154) Device Secondary Predicate Globus COALITION Spacer (K173115); Globus HEDRON Cervical Spacer Device (K191243); LDR Spine Cervical Interbody Fusion System (K091088) Device Description The DOLOMITE Anterior Cervical Stabilization System… | 2019 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 4…ice Secondary Predicate Globus COALITION Spacer (K173115); Globus HEDRON Cervical Spacer Device (K191243); LDR Spine Cervical Interbody Fusion System (K091088) Device Description The DOLOMITE Anterior Cervical Stabilization System are implants developed for the… | 2009 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 245 ancestors have a recall of any class.
- Of its descendants, K242517 (Pro Surgical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K160154.
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. 2020, 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 DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment prior to…
Read the full statement (199 words)
The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment prior to treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.
The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can’t be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202065: DOLOMITE Anterior Cervical Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202065
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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