510(k) · Cleared
Recalled · Class II · 2013Solitaire and Solitaire Peek Anterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 9, 2010 as substantially equivalent to K022143 (Interpore Cross Intl., 2003) and 5 other predicates after a 106-day review. Its family tree reaches back 6 generations to 2001. 143 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K010530 (2001). 31 ancestors in all, the oldest K903810 (1990). 143 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 2 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 1 generation backK081395 Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine · 2008
- This deviceK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010
- Descendant · cites it directly · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled
- Descendant · 2 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
- Descendant · 3 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- Descendant · 4 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
- Descendant · 5 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · cites it directly142descendants
- K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 2 generations on108descendants
- K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 3 generations on93descendants
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 4 generations on72descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 5 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −2 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −1 | K081395 | Solitaire Peek-Optima Anterior Spinal System | Biomet Spine | 2008 | — |
| 0 (this device) | K093629 | Solitaire and Solitaire Peek Anterior Spinal System | Biomet Spine | 2010 | — |
| +1 | K113796 | Solitaire-C Cervical Spacer System | Ebi, LLC | 2012 | 1 |
| +2 | K132029 | Vault-C Intervertebral Body Fusion Device | Spinal USA | 2013 | — |
| +3 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| +4 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | — |
| +5 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 21 | 0 |
| 2025 | 26 | 0 |
| 2026 | 22 | 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 OVD? 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? (6)
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 |
|---|---|---|---|
| * | K022143 | Interpore Cross International Anterior Fixation Device (Afd)Summary page 3…issues of safety or effectiveness. Examples of predicate intervertebral body fusion devices and vertebral replacement devices include the Solitaire™ and Solitaire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma’s Acid Etched Lag Screws (K070955) and the BioDrive® Cann… | 2003 |
| * | K062810 | Solitaire Anterior Spinal SystemSummary page 3…safety or effectiveness. Examples of predicate intervertebral body fusion devices and vertebral replacement devices include the Solitaire™ and Solitaire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma’s Acid Etched Lag Screws (K070955) and the BioDrive® Cannulated Sc… | 2006 |
| * | K081501 | Solitaire Anterior Spinal SystemSummary page 3…r effectiveness. Examples of predicate intervertebral body fusion devices and vertebral replacement devices include the Solitaire™ and Solitaire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma’s Acid Etched Lag Screws (K070955) and the BioDrive® Cannulated Screw Syste… | 2008 |
| * | K081395 | Solitaire Peek-Optima Anterior Spinal SystemSummary page 3…eness. Examples of predicate intervertebral body fusion devices and vertebral replacement devices include the Solitaire™ and Solitaire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma’s Acid Etched Lag Screws (K070955) and the BioDrive® Cannulated Screw System (K082874… | 2008 |
| * | K070955 | Acid Etched Lag ScrewsSummary page 3…replacement devices include the Solitaire™ and Solitaire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma’s Acid Etched Lag Screws (K070955) and the BioDrive® Cannulated Screw System (K082874) as predicates for the proprietary Osseotite® process. Page 5-3 === Page 4… | 2007 |
| * | K082874 | Biodrive Cannulated Screw SystemSummary page 3…aire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma’s Acid Etched Lag Screws (K070955) and the BioDrive® Cannulated Screw System (K082874) as predicates for the proprietary Osseotite® process. Page 5-3 SERVICEs G G, C DEPARTMENT OF HEALTH & HUMAN SE… | 2009 |
What descends from it? (143)
See all 1431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113796 | Solitaire-C Cervical Spacer System | 2012 | 142 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2013 | Class II | Z-2292-2013 | Process control | Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 6 of the 31 ancestors have a recall of any class.
- Of its descendants, K113796 (Ebi, LLC, 2012) has gone furthest, with 142 descendants of its own.
- 2 other devices also cite its predicate K022143.
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. 2010, 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 Solitaire™ and Solitaire™ PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and…
Read the full statement (187 words)
The Solitaire™ and Solitaire™ PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
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/K093629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093629: Solitaire and Solitaire Peek Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093629
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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