510(k) · Cleared
ClearedSolitaire Peek-Optima 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 Jun 25, 2008 as substantially equivalent to K073470 (Stryker Spine, 2008) and 2 other predicates after a 37-day review. Its family tree reaches back 5 generations to 2001. 1 of the 864 devices in its family, counting itself, has a Class I recall. 854 later devices descend from it.
- Decided
- Jun 25, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K010530 (2001). 9 ancestors in all, the oldest P950002 (1996). 854 later devices descend from it, 8 citing it directly. 1 of the 864 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 3 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 2 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 1 generation backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- This deviceK081395 Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine · 2008
- Descendant · cites it directly · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 3 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 480 of its ownK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
Showing 5 of 854 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 854 · See all- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · cites it directly834descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 3 generations on696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
- K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010 · 2 generations on480descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −3 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −2 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −1 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| 0 (this device) | K081395 | Solitaire Peek-Optima Anterior Spinal System | Biomet Spine | 2008 | — |
| +1 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 13 | 0 |
| 2015 | 24 | 0 |
| 2016 | 44 | 0 |
| 2017 | 56 | 0 |
| 2018 | 63 | 0 |
| 2019 | 71 | 0 |
| 2020 | 93 | 0 |
| 2021 | 70 | 1 |
| 2022 | 73 | 0 |
| 2023 | 86 | 0 |
| 2024 | 92 | 0 |
| 2025 | 76 | 0 |
| 2026 | 67 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…ational principles. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes’ SynFix™-LR (K072253) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBI LP (… | 2008 |
| * | K080758 | Avs PL Peek Spacers, Models 48351 and 48353Summary page 1…ciples. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes’ SynFix™-LR (K072253) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBI LP (K022143 & K0… | 2008 |
| * | K072253 | Synfix-LR SpacerSummary page 1…e intervertebral body fusion devices distributed for the similar indications include the Stryker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes’ SynFix™-LR (K072253) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBI LP (K022143 & K062810) and the Interpore Cross Exp… | 2007 |
| † | K022143 | Interpore Cross International Anterior Fixation Device (Afd) | 2003 |
| † | K062810 | Solitaire Anterior Spinal System | 2006 |
| † | K040928 | Expandable Peek VBR Implant | 2004 |
What descends from it? (854)
See all 8548 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083475 | Lucent Magnum | 2009 | 834 |
| K091301 | Life Spine Stand-Alone Spacer System | 2009 | 473 |
| K100802 | Aesculap Implant Systems Sibd Spinal System | 2010 | 461 |
| K093629 | Solitaire and Solitaire Peek Anterior Spinal System | 2010 | 143 |
| K113796 | Solitaire-C Cervical Spacer System | 2012 | 142 |
| K093808 | Incite Innovation Stand Alone Interbody Fusion Device | 2010 | 113 |
| K120557 | Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35 | 2012 | 1 |
| K130641 | Logic Stand-Alone Intervertebral Body Fusion Device | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K083475 (Spinal Elements, Inc., 2009) has gone furthest, with 834 descendants of its own.
- 17 other devices also cite its predicate K073470.
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. 2008, 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™ PEEK-Optima® 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 S1 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.
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/K081395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081395: Solitaire Peek-Optima 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/K081395
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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