510(k) · Cleared
ClearedSolitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Aug 12, 2015 as substantially equivalent to K142152 (Orthofix, Inc., 2015) and 3 other predicates after a 114-day review. Its family tree reaches back 15 generations to 2001. 17 later devices descend from it.
- Decided
- Aug 12, 2015
- Review
- 114 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K003155 (2001). 132 ancestors in all, the oldest K841189 (1984). 17 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 1 generation backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- This deviceK151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System…Biomet Spine · 2015
- Descendant · cites it directly · 15 of its ownK171075 Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
- Descendant · 2 generations on · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · 3 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · 4 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 9 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 8 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 7 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 6 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 5 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 4 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 1 generation backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- This deviceK151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System…Biomet Spine · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017 · cites it directly15descendants
- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · 2 generations on9descendants
- K202305Zavation IBF SystemZavation Medical Products, LLC · 2020 · 2 generations on9descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 3 generations on6descendants
- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −9 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −5 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −2 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −1 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| 0 (this device) | K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System… | Biomet Spine | 2015 | — |
| +1 | K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017 | — |
| +2 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +2 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +3 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +4 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 15 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 18 | 0 |
| 2009 | 10 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemSummary page 6…Cervical (ODP) (Product Code): Device Panel - Regulation Orthopedic - 21 CFR § 888.3080 No.: Primary Predicate: CONSTRUX Mini PEEK Spacer System (K142152) Solitaire®-C Cervical Spacer System (K113796) C-Thru™ Anteri… | 2015 |
| * | K113796 | Solitaire-C Cervical Spacer SystemSummary page 6…1 CFR § 888.3080 No.: Primary Predicate: CONSTRUX Mini PEEK Spacer System (K142152) Solitaire®-C Cervical Spacer System (K113796) C-Thru™ Anterior Spinal System ( K092336) Other Predicates:… | 2012 |
| * | K092336 | C-Thru Spinal SystemSummary page 6…pacer System (K142152) Solitaire®-C Cervical Spacer System (K113796) C-Thru™ Anterior Spinal System ( K092336) Other Predicates: Breckenridge® Small Intervertebral Body Fusion System… | 2009 |
| * | K103660 | Lanx Cervical Intervertebral Body Fusion SystemSummary page 6…ior Spinal System ( K092336) Other Predicates: Breckenridge® Small Intervertebral Body Fusion System (K103660) Device Description: The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenou… | 2011 |
What descends from it? (17)
See all 172 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 14 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 16 of the 132 ancestors have a recall of any class.
- Of its descendants, K171075 (X-Spine Systems, Inc., 2017) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K142152.
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. 2015, 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?
When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease (“DDD”) at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration…
Read the full statement (343 words)
When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease (“DDD”) at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.
When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.
The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151064: Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151064
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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