510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Solitaire-C Cervical Spacer System

K113796510(k) TraditionalCleared Apr 26, 2012125-day reviewClass II21 CFR 888.3080Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ebi, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Apr 26, 2012 as substantially equivalent to K081395 (Biomet Spine, 2008) and 6 other predicates after a 125-day review. Its family tree reaches back 11 generations to 1984. 142 later devices descend from it. It has been recalled once.

Decided
Apr 26, 2012
Review
125 days
Class
Class II
Product code
OVE
Recalls
1
Predicates
7

Its longest line of descent runs back 11 generations to K841189 (1984). 83 ancestors in all. 142 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2009: 5 other ancestors2008: 11 other ancestors2007: 6 other ancestors2006: 2 other ancestors2004: 6 other ancestors2003: 6 other ancestors2002: 8 other ancestors2001: 11 other ancestors2005: 3 other ancestors1999: 1 other ancestor1996: 6 other ancestors2000: 2 other ancestors1990: 1 other ancestor1992: 2 other ancestors2015: 2 descendants cleared2016: 3 descendants cleared2013: 2 descendants cleared2017: 5 descendants cleared2022: 19 descendants cleared2024: 21 descendants cleared2019: 2 descendants cleared2021: 11 descendants cleared2020: 7 descendants cleared2026: 22 descendants cleared2018: 1 descendant cleared2023: 21 descendants cleared2025: 26 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) K102606 · Avs Anchor-C Cervical Cage System · Stryker Spine · 2011 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 19 other ancestors3 generations back: 22 other ancestors4 generations back: 10 other ancestors5 generations back: 8 other ancestors6 generations back: 5 other ancestors7 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 14 descendants3 generations forward: 26 descendants4 generations forward: 28 descendants5 generations forward: 13 descendants6 generations forward: 12 descendants7 generations forward: 18 descendants8 generations forward: 17 descendants9 generations forward: 9 descendants10 generations forward: 1 descendant K102606 · Avs Anchor-C Cervical Cage System · Stryker Spine · 2011 · recalledK091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5+10
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  4. 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  5. 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
  6. This deviceK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012
  7. Descendant · cites it directly · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  8. Descendant · 2 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  9. Descendant · 3 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
  10. Descendant · 4 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
  11. Descendant · 5 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
  12. This deviceK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012

Showing 5 of 142 descendants. See all descendants

Descendants cleared per year

2013: 22015: 22016: 32017: 52018: 12019: 22020: 72021: 112022: 192023: 212024: 212025: 262026: 22
2013high 26 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 142 · See all
  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · cites it directly108descendants
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 2 generations on93descendants
  • K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 3 generations on72descendants
  • K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 4 generations on67descendants
  • K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 5 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−7K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−6K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−5K043479MC+ Partial VBRLdr Spine USA2005—
−4K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−3K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
−1K102606Avs Anchor-C Cervical Cage SystemStryker Spine20111
0 (this device)K113796Solitaire-C Cervical Spacer SystemEbi, LLC2012—
+1K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC2020—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.2020—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199220
199660
199910
200020
2001110
200280
200360
200460
200530
200620
200760
2008110
200950
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201520
201630
201750
201810
201920
202070
2021110
2022190
2023210
2024210
2025260
2026220
FIG. 1 — Lineage of K113796, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K081395Solitaire Peek-Optima Anterior Spinal System
Summary page 1
…al Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Solitaire PEEK Anterior Spinal System (Biomet Spine - K081395, K093629) * Coalition Spacer (Globus Medical .- K083389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-…
Biomet Spine2008—
*K093629Solitaire and Solitaire Peek Anterior Spinal System
Summary page 1
…System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Solitaire PEEK Anterior Spinal System (Biomet Spine - K081395, K093629) * Coalition Spacer (Globus Medical .- K083389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-P Cervica…
Biomet Spine20101
*K083389Coalition Spacer
Summary page 1
…e devices. Examples of predicate devices include: * Solitaire PEEK Anterior Spinal System (Biomet Spine - K081395, K093629) * Coalition Spacer (Globus Medical .- K083389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-P Cervical Spacer (Synthes Spine - K072981, K093762) * C…
Globus Medical, Inc.2009—
*K102606Avs Anchor-C Cervical Cage System
Summary page 1
…ude: * Solitaire PEEK Anterior Spinal System (Biomet Spine - K081395, K093629) * Coalition Spacer (Globus Medical .- K083389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-P Cervical Spacer (Synthes Spine - K072981, K093762) * C-Thru Spacer System (Biomet Spine - K092336)…
Stryker Spine20111
*K072981Synthes Zero-P
Summary page 1
…81395, K093629) * Coalition Spacer (Globus Medical .- K083389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-P Cervical Spacer (Synthes Spine - K072981, K093762) * C-Thru Spacer System (Biomet Spine - K092336)…
Synthes Spine Co.Lp20082
*K093762Synthes Zero-P
Summary page 1
…93629) * Coalition Spacer (Globus Medical .- K083389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-P Cervical Spacer (Synthes Spine - K072981, K093762) * C-Thru Spacer System (Biomet Spine - K092336)…
Synthes Spine20101
*K092336C-Thru Spinal System
Summary page 1
…3389) * AVS-C Spacer (Stryker Spine - K 102606) * Synthes Zero-P Cervical Spacer (Synthes Spine - K072981, K093762) * C-Thru Spacer System (Biomet Spine - K092336) Page 5-2 === Pa…
Ebi, L.P.2009—

Also cleared against K081395: 7 other devices →

What descends from it? (142)

See all 142

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108
K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629
K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324
K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 11, 2014Class IIZ-0874-2015Device DesignA design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
  • 13 of the 83 ancestors have a recall of any class.
  • Of its descendants, K132029 (Spinal USA, 2013) has gone furthest, with 108 descendants of its own.
  • 7 other devices also cite its predicate K081395.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

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 TI. 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…

Read the full statement (114 words)

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 TI. 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 Solitaireo-C Cervical Spacer System is to be used with autograft 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.

Also cleared against K081395

7 other devices cite the same predicate.

  • K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc. · 2013
  • K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies · 2012
  • K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  • K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC · 2010
  • K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 20101 recall
  • K091301Life Spine Stand-Alone Spacer SystemLife Spine · 2009

More from Ebi, LLC

4 FDA decisions under this applicant name. See the company

  • K140734Nextgen Altius Oct SystemEbi, LLC · 2014
  • K140123Polaris Spinal System -Translation ScrewEbi, LLC · 20141 recall
  • K111376Construx External Fixation DeviceEbi, LLC · 20111 recall

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K113796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113796: Solitaire-C Cervical Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113796

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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