510(k) · Cleared
ClearedPatriot Spacers: Colonial Acdf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 18, 2008 after an 87-day review. The FDA summary names no predicate by number. 1 of the 648 devices in its family, counting itself, has a Class I recall. 647 later devices descend from it.
- Decided
- Jan 18, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
647 later devices descend from it, 11 citing it directly. 1 of the 648 devices in this family, counting this one, has a Class I recall.
- This deviceK072991 Patriot Spacers: Colonial AcdfGlobus Medical, Inc. · 2008
- Descendant · cites it directly · 633 of its ownK083389 Coalition SpacerGlobus Medical, Inc. · 2009
- Descendant · 2 generations on · 405 of its ownK122630 IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012
- Descendant · 2 generations on · 345 of its ownK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · cites it directly · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
Showing 5 of 647 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 647 · See all- K083389Coalition SpacerGlobus Medical, Inc. · 2009 · cites it directly633descendants
- K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012 · 2 generations on405descendants
- K111439Chesapeake (Cervical Components)K2m, Inc. · 2011 · 2 generations on345descendants
- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 3 generations on330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · cites it directly315descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072991 | Patriot Spacers: Colonial Acdf | Globus Medical, Inc. | 2008 | — |
| +1 | K083389 | Coalition Spacer | Globus Medical, Inc. | 2009 | — |
| +2 | K122630 | IN:C2 Spinal Fixation System | Spine Smith Partners L.P. | 2012 | — |
| +2 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| +3 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +1 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 22 | 0 |
| 2016 | 21 | 0 |
| 2017 | 48 | 0 |
| 2018 | 38 | 0 |
| 2019 | 45 | 0 |
| 2020 | 58 | 0 |
| 2021 | 55 | 1 |
| 2022 | 61 | 0 |
| 2023 | 74 | 0 |
| 2024 | 69 | 0 |
| 2025 | 65 | 0 |
| 2026 | 62 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (647)
See all 64711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083389 | Coalition Spacer | 2009 | 633 |
| K160125 | Cascadia Interbody System | 2016 | 315 |
| K130478 | Sustain and Sustain Radiolucent Spacers | 2013 | 256 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K120275 | Synthes Acis/Vertebral Spacer CR | 2012 | 173 |
| K142218 | Coalition AGX Plate and Coalition AGX Spacer | 2015 | 155 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | 2018 | 94 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K162402 | 4CIS® Marlin ACIF Cage System | 2017 | 1 |
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, K083389 (Globus Medical, Inc., 2009) has gone furthest, with 633 descendants of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
PATRIOTTM Spacers (ColonialTM ACDF) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic 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) weeks of non-operative treatment.
PATRIOTTMSpacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE@or PROVIDENCE@Anterior Cervical Plate System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072991: Patriot Spacers: Colonial Acdf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072991
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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