510(k) · Cleared
ClearedIntercontinental Plate-Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 20, 2011 as substantially equivalent to K082252 (Globus Medical, Inc., 2008) and 2 other predicates after a 183-day review. Its family tree reaches back 10 generations to 1984. 1 of the 575 devices in its family, counting itself, has a Class I recall. 554 later devices descend from it.
- Decided
- May 20, 2011
- Review
- 183 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K841189 (1984). 20 ancestors in all. 554 later devices descend from it, 13 citing it directly. 1 of the 575 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 deviceK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 466 of its ownK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
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 deviceK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
Showing 5 of 554 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 554 · See all- K131723Coroent Single Tab SystemNuvasive, Inc. · 2013 · cites it directly466descendants
- K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · cites it directly465descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 2 generations on396descendants
- K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 2 generations on390descendants
- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on381descendants
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) | K103382 | Intercontinental Plate-Spacer | Globus Medical, Inc. | 2011 | — |
| +1 | K131723 | Coroent Single Tab System | Nuvasive, Inc. | 2013 | — |
| +1 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 17 | 0 |
| 2017 | 25 | 0 |
| 2018 | 29 | 0 |
| 2019 | 34 | 0 |
| 2020 | 53 | 0 |
| 2021 | 49 | 1 |
| 2022 | 58 | 0 |
| 2023 | 67 | 0 |
| 2024 | 84 | 0 |
| 2025 | 69 | 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.
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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K082252 | Independence SpacerSummary page 1…tervertebral Body Fusion Device Product Code: OVID Regulatory Class: 11,Panel Code: 87 Predicate(s): INDEPENDENCE® Spacer (K082252) PATRIOT®8 TransContinenta l T m LLIF Spacer (K093242) CoRoent®.XL-F (K071795) Purpose:… | 2008 |
| * | K093242 | Patriot Transcontinental Llif SpacerSummary page 1…Regulatory Class: 11,Panel Code: 87 Predicate(s): INDEPENDENCE® Spacer (K082252) PATRIOT®8 TransContinenta l T m LLIF Spacer (K093242) CoRoent®.XL-F (K071795) Purpose: The purpose of this submission is clearance of the lnterContinentalTM Plat… | 2009 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…Code: 87 Predicate(s): INDEPENDENCE® Spacer (K082252) PATRIOT®8 TransContinenta l T m LLIF Spacer (K093242) CoRoent®.XL-F (K071795) Purpose: The purpose of this submission is clearance of the lnterContinentalTM Plate- Spacer as a modification of the cleared I… | 2007 |
What descends from it? (554)
See all 55413 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131723 | Coroent Single Tab System | 2013 | 466 |
| K140479 | Coroent XL-F System | 2014 | 465 |
| K120101 | Independence Spacer | 2012 | 224 |
| K113285 | LDR Spine Usa Avenue L Interbody Fusion | 2012 | 199 |
| K161379 | ELSA Spacers | 2016 | 155 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K131276 | Lateral Synfix | 2014 | 146 |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | 2016 | 117 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental… | 2021 | 35 |
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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K131723 (Nuvasive, Inc., 2013) has gone furthest, with 466 descendants of its own.
- 12 other devices also cite its predicate K082252.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The InterContinental Plate-Spacer is an interbody fusion device 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…
Read the full statement (123 words)
The InterContinental Plate-Spacer is an interbody fusion device 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterContinental Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103382: Intercontinental Plate-Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103382
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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