510(k) · Cleared
ClearedTransContinental® M Spacers and InterContinental® Plate-Spacers
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 Jul 15, 2016 as substantially equivalent to K140479 (Nu Vasive, Incorporated, 2014) and 5 other predicates after a 77-day review. Its family tree reaches back 15 generations to 1984. 117 later devices descend from it.
- Decided
- Jul 15, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 201 ancestors in all, the oldest K792352 (1979). 117 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- This deviceK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 55 of its ownK171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 36 of its ownK201087 CORBEL SpacersGlobus Medical, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- This deviceK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · cites it directly97descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 2 generations on84descendants
- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc. · 2017 · cites it directly55descendants
- K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · 2 generations on37descendants
- K201087CORBEL SpacersGlobus Medical, Inc. · 2020 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −1 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| 0 (this device) | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +2 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers… | Globus Medical, Inc. | 2017 | — |
| +2 | K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 | — |
| +3 | K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 24 | 0 |
| 2005 | 15 | 0 |
| 2006 | 12 | 0 |
| 2007 | 14 | 0 |
| 2008 | 26 | 0 |
| 2009 | 13 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 18 | 0 |
| 2024 | 30 | 0 |
| 2025 | 22 | 0 |
| 2026 | 19 | 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 OVD? 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? (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 |
|---|---|---|---|
| * | K140479 | Coroent XL-F SystemSummary page 5…ervertebral Body Fusion Device Product Codes: OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: NuVasive CoRoent (K140479 & K141665) Additional TransContinental® M Spacers (K102313 & K122097) Predicates: InterContinental® Plate-Space… | 2014 |
| * | K141665 | NuVasive CoRoent SystemSummary page 5…l Body Fusion Device Product Codes: OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: NuVasive CoRoent (K140479 & K141665) Additional TransContinental® M Spacers (K102313 & K122097) Predicates: InterContinental® Plate-Spacer (K103382… | 2015 |
| * | K102313 | Patriot Transcontinental M SpacersSummary page 5…, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: NuVasive CoRoent (K140479 & K141665) Additional TransContinental® M Spacers (K102313 & K122097) Predicates: InterContinental® Plate-Spacer (K103382) TPS Spacers (K143578) Purpose: The p… | 2010 |
| * | K122097 | Patriot SpacersSummary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: NuVasive CoRoent (K140479 & K141665) Additional TransContinental® M Spacers (K102313 & K122097) Predicates: InterContinental® Plate-Spacer (K103382) TPS Spacers (K143578) Purpose: The purpose of… | 2012 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 5…Predicate: NuVasive CoRoent (K140479 & K141665) Additional TransContinental® M Spacers (K102313 & K122097) Predicates: InterContinental® Plate-Spacer (K103382) TPS Spacers (K143578) Purpose: The purpose of this submission is to request clearance for TransContinental®… | 2011 |
| * | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Summary page 5…41665) Additional TransContinental® M Spacers (K102313 & K122097) Predicates: InterContinental® Plate-Spacer (K103382) TPS Spacers (K143578) Purpose: The purpose of this submission is to request clearance for TransContinental® M and InterContinental® Additional Implan… | 2016 |
What descends from it? (117)
See all 1173 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 32 years and passes through 13 companies; a new generation was cleared every 1.3 years on median.
- 24 of the 201 ancestors have a recall of any class.
- Of its descendants, K181357 (Globus Medical, Inc., 2018) has gone furthest, with 97 descendants of its own.
- 7 other devices also cite its predicate K140479.
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. 2016, 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?
PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) 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 as confirmed by…
Read the full statement (292 words)
PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) 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 as 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). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (•20° lordosis) must be used with at least anterior supplemental fixation.
InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar 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 1 spondylolisthesis or retrolisthesis at the involved level(s). InterContinental® Plate-Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161223
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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