510(k) · Cleared
ClearedPatriot Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 18, 2008 after an 88-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 1,095 devices in its family, counting itself, has a Class I recall. 1,094 later devices descend from it.
- Decided
- Jan 18, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
1,094 later devices descend from it, 29 citing it directly. 1 of the 1,095 devices in this family, counting this one, has a Class I recall.
- This deviceK072970 Patriot SpacersGlobus Medical, Inc. · 2008
- Descendant · cites it directly · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- Descendant · cites it directly · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- Descendant · 2 generations on · 718 of its ownK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
- Descendant · 2 generations on · 691 of its ownK113447 Rise SpacerGlobus Medical, Inc. · 2012
- Descendant · 3 generations on · 682 of its ownK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
Showing 5 of 1,094 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 1,094 · See all- K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · cites it directly921descendants
- K102293Caliber SpacerGlobus Medical, Inc. · 2011 · cites it directly869descendants
- K113465Acculif TL CageCoalign Innovations, Inc. · 2011 · 2 generations on718descendants
- K113447Rise SpacerGlobus Medical, Inc. · 2012 · 2 generations on691descendants
- K121683Acculif TL CageCoalign Innovations, Inc. · 2012 · 3 generations on682descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072970 | Patriot Spacers | Globus Medical, Inc. | 2008 | — |
| +1 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| +1 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| +2 | K113465 | Acculif TL Cage | Coalign Innovations, Inc. | 2011 | — |
| +2 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| +3 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 15 | 0 |
| 2012 | 20 | 0 |
| 2013 | 25 | 0 |
| 2014 | 36 | 0 |
| 2015 | 45 | 0 |
| 2016 | 67 | 0 |
| 2017 | 91 | 0 |
| 2018 | 77 | 0 |
| 2019 | 89 | 0 |
| 2020 | 96 | 0 |
| 2021 | 82 | 1 |
| 2022 | 84 | 0 |
| 2023 | 102 | 0 |
| 2024 | 96 | 0 |
| 2025 | 82 | 0 |
| 2026 | 77 | 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 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P95002 | BAK Interbody Fusion System Number could not be read Summary page 1…TransContinentalTM LLIF Spacer Classification: Product Code MAX. Class II. 21 CFR §888.3080 Intervertebral body fusion device Predicate(s): P95002 BAK Interbody Fusion System Device Description: The PATRIOT T M Spacers (Constitution TM PLIF, Signature MT TLIF, ContinentalTM… |
What descends from it? (1,094)
See all 1,09429 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093242 | Patriot Transcontinental Llif Spacer | 2009 | 921 |
| K102293 | Caliber Spacer | 2011 | 869 |
| K082801 | Phantom Plus Cage System | 2008 | 643 |
| K110454 | Cougar LS Lateral Cage System | 2011 | 602 |
| K082252 | Independence Spacer | 2008 | 576 |
| K102313 | Patriot Transcontinental M Spacers | 2010 | 361 |
| K122097 | Patriot Spacers | 2012 | 261 |
| K130478 | Sustain and Sustain Radiolucent Spacers | 2013 | 256 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K140411 | Altera Spacer | 2014 | 191 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K093242 (Globus Medical, Inc., 2009) has gone furthest, with 921 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?
PATRIOT TM Spacers (Constitution T M PLIF, Continental T M ALIF, TransContinentalTM LLIF and Signature TM TLIF Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at…
Read the full statement (124 words)
PATRIOT TM Spacers (Constitution T M PLIF, Continental T M ALIF, TransContinentalTM LLIF and Signature TM TLIF Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
PATRIOTTM Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072970: Patriot Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072970
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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