510(k) · Cleared
ClearedIntegra Cervical and Petra Plif Lumbar Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calvary Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 17, 2008 after a 70-day review. The FDA summary names no predicate by number. 562 later devices descend from it.
- Decided
- Oct 17, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
562 later devices descend from it, 2 citing it directly.
- This deviceK082260 Integra Cervical and Petra Plif Lumbar CagesCalvary Spine, LLC · 2008
- Descendant · cites it directly · 481 of its ownK110733 Daytona Anterior Cervical CageSpinenet, LLC · 2011 · Recalled
- Descendant · 2 generations on · 454 of its ownK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- Descendant · 3 generations on · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- Descendant · 4 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
Showing 5 of 562 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 562 · See all- K110733Daytona Anterior Cervical CageSpinenet, LLC · 2011 · cites it directly481descendants
- K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013 · 2 generations on454descendants
- K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · 3 generations on453descendants
- K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 4 generations on449descendants
- K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · 4 generations on444descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082260 | Integra Cervical and Petra Plif Lumbar Cages | Calvary Spine, LLC | 2008 | — |
| +1 | K110733 | Daytona Anterior Cervical Cage | Spinenet, LLC | 2011 | 1 |
| +2 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| +3 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| +4 | K142050 | Nuvasive Coroent Small Contoured Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 25 | 0 |
| 2018 | 33 | 0 |
| 2019 | 35 | 0 |
| 2020 | 60 | 0 |
| 2021 | 49 | 0 |
| 2022 | 59 | 0 |
| 2023 | 80 | 0 |
| 2024 | 72 | 0 |
| 2025 | 64 | 0 |
| 2026 | 58 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (562)
See all 5622 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?
- Of its descendants, K110733 (Spinenet, LLC, 2011) has gone furthest, with 481 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Integra Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3…
Read the full statement (223 words)
The Integra Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autogenous bone graft. Integra Cervical implant is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Petra PLIF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Petra PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082260: Integra Cervical and Petra Plif Lumbar Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082260
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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