510(k) · Cleared
ClearedLatis Spacer
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 May 13, 2013 as substantially equivalent to K072970 (Globus Medical, Inc., 2008) and 4 other predicates after a 145-day review. Its family tree reaches back 11 generations to 1984. 88 later devices descend from it.
- Decided
- May 13, 2013
- Review
- 145 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 37 ancestors in all. 88 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
- This deviceK123913 Latis SpacerGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 55 of its ownK171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 41 of its ownK160646 XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc. · 2016
- Descendant · 2 generations on · 39 of its ownK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 3 generations on · 38 of its ownK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
- This deviceK123913 Latis SpacerGlobus Medical, Inc. · 2013
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc. · 2017 · cites it directly55descendants
- K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc. · 2016 · cites it directly41descendants
- K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020 · 2 generations on39descendants
- K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc. · 2021 · 3 generations on38descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K102313 | Patriot Transcontinental M Spacers | Globus Medical, Inc. | 2010 | — |
| 0 (this device) | K123913 | Latis Spacer | Globus Medical, Inc. | 2013 | — |
| +1 | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers… | Globus Medical, Inc. | 2017 | — |
| +1 | K160646 | XYcor® Expandable Spinal Spacer System | Alphatec Spine, Inc. | 2016 | — |
| +2 | K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +3 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
| +4 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 13 | 0 |
| 2024 | 18 | 0 |
| 2025 | 19 | 0 |
| 2026 | 15 | 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 MAX? 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? (5)
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 Devices. Product Code: MAX. Regulatory Class 11,Panel Code: 87. Predicate(s): PATRIOT®"(K072970, K093242, & K1 02313) Custom Spine PATHWAY AVID TM Spacers (K1 11726) Vertebral Technologies… | 2008 |
| * | K093242 | Patriot Transcontinental Llif SpacerSummary page 1…888.3080 Intervertebral Body Fusion Devices. Product Code: MAX. Regulatory Class 11,Panel Code: 87. Predicate(s): PATRIOT®"(K072970, K093242, & K1 02313) Custom Spine PATHWAY AVID TM Spacers (K1 11726) Vertebral Technologies lnter-Fus… | 2009 |
| * | K102313 | Patriot Transcontinental M SpacersSummary page 1…tervertebral Body Fusion Devices. Product Code: MAX. Regulatory Class 11,Panel Code: 87. Predicate(s): PATRIOT®"(K072970, K093242, & K1 02313) Custom Spine PATHWAY AVID TM Spacers (K1 11726) Vertebral Technologies lnter-Fuse®T (K1 1022… | 2010 |
| * | K111726 | Pathway AvidSummary page 1…X. Regulatory Class 11,Panel Code: 87. Predicate(s): PATRIOT®"(K072970, K093242, & K1 02313) Custom Spine PATHWAY AVID TM Spacers (K1 11726) Vertebral Technologies lnter-Fuse®T (K1 10226) Purpose: The purpose of this submission is to request clearanc… | 2012 |
| * | K110226 | Interfuse T Invertebral Body Fusion DeviceSummary page 1…(s): PATRIOT®"(K072970, K093242, & K1 02313) Custom Spine PATHWAY AVID TM Spacers (K1 11726) Vertebral Technologies lnter-Fuse®T (K1 10226) Purpose: The purpose of this submission is to request clearance for the LATISTM Spacers a modification of the cleared PATRIOT®0… | 2011 |
What descends from it? (88)
See all 885 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K160646 | XYcor® Expandable Spinal Spacer System | 2016 | 41 |
| K133717 | Longbow Spacer System | 2014 | 9 |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | 2023 | 2 |
| K153356 | Spine Innovation Interbody System | 2016 | 1 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 37 ancestors have a recall of any class.
- Of its descendants, K171848 (Globus Medical, Inc., 2017) has gone furthest, with 55 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. 2013, 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?
LATISTM 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 (L-2-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).
LATI STM 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/K123913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123913: Latis Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123913
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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