510(k) · Cleared
ClearedIncite Innovation Stand Alone Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incite Innovation, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 24, 2010 as substantially equivalent to K082262 (Ldr Spine USA, 2009) and 3 other predicates after a 103-day review. Its family tree reaches back 6 generations to 2001. 113 later devices descend from it.
- Decided
- Mar 24, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K010530 (2001). 11 ancestors in all, the oldest P950002 (1996). 113 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 deviceK093808 Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC · 2010
- Descendant · cites it directly · 112 of its ownK102402 Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011 · cites it directly112descendants
- K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · 2 generations on110descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 4 generations on69descendants
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) | K093808 | Incite Innovation Stand Alone Interbody Fusion Device | Incite Innovation, LLC | 2010 | — |
| +1 | K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System | Alphatec Spine, Inc. | 2011 | 1 |
| +2 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +3 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +4 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 17 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 21 | 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? (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 |
|---|---|---|---|
| * | K082262 | LDR Spine Roi Interbody Fusion SystemSummary page 1…dy fusion device, 21 CFR Part 888.3080, MAX Class Il, Special Controls Predicate Devices LDR ROI - A™ ALIF Cage with Vertebridge™ Technology and LOR ROI-T TLIF Cage (K082262) Synthes Synfix™-LR System (K072253) Biomet Solitaire™ PEEK-Optima® Anterior Spinal System (K081395) Spine-Tech BAK™ Interbody F… | 2009 |
| * | K072253 | Synfix-LR SpacerSummary page 1…0, MAX Class Il, Special Controls Predicate Devices LDR ROI - A™ ALIF Cage with Vertebridge™ Technology and LOR ROI-T TLIF Cage (K082262) Synthes Synfix™-LR System (K072253) Biomet Solitaire™ PEEK-Optima® Anterior Spinal System (K081395) Spine-Tech BAK™ Interbody Fusion System (P950002) Device Descri… | 2007 |
| * | K081395 | Solitaire Peek-Optima Anterior Spinal SystemSummary page 1…- A™ ALIF Cage with Vertebridge™ Technology and LOR ROI-T TLIF Cage (K082262) Synthes Synfix™-LR System (K072253) Biomet Solitaire™ PEEK-Optima® Anterior Spinal System (K081395) Spine-Tech BAK™ Interbody Fusion System (P950002) Device Description The Incite Interbody Fusion Device (IBFD) is an ALIF impl… | 2008 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…R ROI-T TLIF Cage (K082262) Synthes Synfix™-LR System (K072253) Biomet Solitaire™ PEEK-Optima® Anterior Spinal System (K081395) Spine-Tech BAK™ Interbody Fusion System (P950002) Device Description The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates the benefit of a radiolucent… | 1996 |
What descends from it? (113)
See all 1131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System | 2011 | 112 |
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 9 years and passes through 6 companies; a new generation was cleared every 6 months on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K102402 (Alphatec Spine, Inc., 2011) has gone furthest, with 112 descendants of its own.
- 7 other devices also cite its predicate K082262.
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 Incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients treated should be skeletally mature and have received a minimum of six months of non-operative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.
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/K093808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093808: Incite Innovation Stand Alone Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093808
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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