510(k) · Cleared
ClearedPatriot Transcontinental M 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 Dec 3, 2010 as substantially equivalent to K072970 (Globus Medical, Inc., 2008) and 1 other predicate after a 109-day review. Its family tree reaches back 10 generations to 1984. 1 of the 381 devices in its family, counting itself, has a Class I recall. 361 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 109 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K841189 (1984). 19 ancestors in all. 361 later devices descend from it, 9 citing it directly. 1 of the 381 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 2 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 1 generation backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- This deviceK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
- Descendant · cites it directly · 261 of its ownK122097 Patriot SpacersGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · 2 generations on · 191 of its ownK140411 Altera SpacerGlobus Medical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 175 of its ownK142498 MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 6 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 2 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 1 generation backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- This deviceK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
Showing 5 of 361 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 361 · See all- K122097Patriot SpacersGlobus Medical, Inc. · 2012 · cites it directly261descendants
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
- K140411Altera SpacerGlobus Medical, Inc. · 2014 · 2 generations on191descendants
- K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015 · 2 generations on175descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −6 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −2 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −1 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| 0 (this device) | K102313 | Patriot Transcontinental M Spacers | Globus Medical, Inc. | 2010 | — |
| +1 | K122097 | Patriot Spacers | Globus Medical, Inc. | 2012 | — |
| +1 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +2 | K140411 | Altera Spacer | Globus Medical, Inc. | 2014 | 22 |
| +2 | K142498 | MAGNIFY and MAGNIFY-S Spacers | Globus Medical, Inc. | 2015 | — |
| +1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 15 | 0 |
| 2019 | 20 | 0 |
| 2020 | 26 | 0 |
| 2021 | 30 | 1 |
| 2022 | 37 | 0 |
| 2023 | 46 | 0 |
| 2024 | 56 | 0 |
| 2025 | 55 | 0 |
| 2026 | 47 | 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? (2)
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 |
|---|---|---|---|
| * | K072970 | Patriot SpacersSummary page 1…§888.3080 Intervertebral Body Fusion Device Product Code MAX. Regulatory Class 11,Panel Code 87 Predicate(s): PATRIOT® Lumbar Spacers K072970 SE date January 16, 2008 PATRIOT® TransContinental LLI F Spacers K093242 SE d… | 2008 |
| * | K093242 | Patriot Transcontinental Llif SpacerSummary page 1…lass 11,Panel Code 87 Predicate(s): PATRIOT® Lumbar Spacers K072970 SE date January 16, 2008 PATRIOT® TransContinental LLI F Spacers K093242 SE date December 23, 2009 Purpose: The purpose of this submission is clearance of the PATRIOT® TransContinenta… | 2009 |
What descends from it? (361)
See all 3619 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122097 | Patriot Spacers | 2012 | 261 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K123180 | Falcon Spacer | 2013 | 147 |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | 2016 | 117 |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | 2018 | 97 |
| K123913 | Latis Spacer | 2013 | 88 |
| K160463 | Reliance Lumbar IBF System | 2016 | 11 |
| K180687 | Reliance Lumber IBF System | 2018 | 8 |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K122097 (Globus Medical, Inc., 2012) has gone furthest, with 261 descendants of its own.
- 28 other devices also cite its predicate K072970.
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. 2010, 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 PATRIOT® TransContinentaTM M 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). OIDD 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…
Read the full statement (108 words)
The PATRIOT® TransContinentaTM M 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). OIDD 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 1 spondylolisthesis or retrolisthesis at the involved
level(s).
The PATRIOT® TransContinenta T M M Spacers are to be filled with autogenous
bone graft material. These devices are intended to be used with supplemental
fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102313: Patriot Transcontinental M Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102313
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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