510(k) · Cleared
ClearedPATRIOT COLONIAL Spacer, SUSTAIN Spacer
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 May 23, 2018 as substantially equivalent to K072991 (Globus Medical, Inc., 2008) and 5 other predicates after a 169-day review. Its family tree reaches back 16 generations to 2001. 94 later devices descend from it.
- Decided
- May 23, 2018
- Review
- 169 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K003155 (2001). 180 ancestors in all, the oldest K792352 (1979). 94 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
- This deviceK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 60 of its ownK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 39 of its ownK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 2 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 10 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 9 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 8 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 7 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 6 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 5 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
- This deviceK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019 · cites it directly60descendants
- K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2021 · 2 generations on39descendants
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · cites it directly36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −10 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −6 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −5 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −3 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −1 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015 | — |
| 0 (this device) | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | 2018 | — |
| +1 | K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +2 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 23 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 20 | 0 |
| 2009 | 14 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 14 | 0 |
| 2024 | 20 | 0 |
| 2025 | 24 | 0 |
| 2026 | 16 | 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 ODP? 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? (6)
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 |
|---|---|---|---|
| * | K072991 | Patriot Spacers: Colonial AcdfSummary page 5…bral Body Fusion Device Product Codes: ODP Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® COLONIAL® Spacers (K072991) Additional Predicates: PATRIOT® COLONIAL® Spacers (K143578) SUSTAIN® Spacers (K130478, K143578)… | 2008 |
| * | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Summary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® COLONIAL® Spacers (K072991) Additional Predicates: PATRIOT® COLONIAL® Spacers (K143578) SUSTAIN® Spacers (K130478, K143578) NuVasive CoRoent Small Interbody (K163491)… | 2016 |
| * | K130478 | Sustain and Sustain Radiolucent SpacersSummary page 5…87 Primary Predicate: PATRIOT® COLONIAL® Spacers (K072991) Additional Predicates: PATRIOT® COLONIAL® Spacers (K143578) SUSTAIN® Spacers (K130478, K143578) NuVasive CoRoent Small Interbody (K163491) Orthofix CONSTRUX Mini PEEK Spacer… | 2013 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 5…Predicates: PATRIOT® COLONIAL® Spacers (K143578) SUSTAIN® Spacers (K130478, K143578) NuVasive CoRoent Small Interbody (K163491) Orthofix CONSTRUX Mini PEEK Spacer (K150619) Medtronic Cornerstone® PSR (K153373) Refe… | 2017 |
| * | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemSummary page 5…SUSTAIN® Spacers (K130478, K143578) NuVasive CoRoent Small Interbody (K163491) Orthofix CONSTRUX Mini PEEK Spacer (K150619) Medtronic Cornerstone® PSR (K153373) Reference Devices: NuVasive CoRoent Small Interlock (K1614… | 2015 |
| * | K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Summary page 5…NuVasive CoRoent Small Interbody (K163491) Orthofix CONSTRUX Mini PEEK Spacer (K150619) Medtronic Cornerstone® PSR (K153373) Reference Devices: NuVasive CoRoent Small Interlock (K161442) UNIFY® Dynamic Anterior Cervical… | 2016 |
| † | K161442 | NuVasive® CoRoent® Small Interlock™ System | 2016 |
| † | K121049 | Unify Dynamic Anterior Cervical Plate System | 2012 |
What descends from it? (94)
See all 945 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?
- The line of descent spans 17 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 19 of the 180 ancestors have a recall of any class.
- Of its descendants, K183083 (SeaSpine Orthopedics Corporation, 2019) has gone furthest, with 60 descendants of its own.
- 10 other devices also cite its predicate K072991.
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. 2018, 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?
PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte…
Read the full statement (303 words)
PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.
PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers including SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.
SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173722: PATRIOT COLONIAL Spacer, SUSTAIN Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173722
Report an extraction error
Are you the manufacturer?
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