510(k) · Cleared
Recalled · Class II · 2020Altera 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 Jul 1, 2014 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 3 other predicates after a 133-day review. Its family tree reaches back 13 generations to 1984. 1 of the 219 devices in its family, counting itself, has a Class I recall. 191 later devices descend from it. It has been recalled 22 times.
- Decided
- Jul 1, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 22
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 27 ancestors in all. 191 later devices descend from it, 8 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 1 generation backK122097 Patriot SpacersGlobus Medical, Inc. · 2012
- This deviceK140411 Altera SpacerGlobus Medical, Inc. · 2014
- Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · 3 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 55 of its ownK171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy…Globus Medical, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 9 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 8 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 5 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 4 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 1 generation backK122097 Patriot SpacersGlobus Medical, Inc. · 2012
- This deviceK140411 Altera SpacerGlobus Medical, Inc. · 2014
Showing 5 of 191 descendants. See all descendants
Descendants cleared per year
2017high 40 (2024) · low 2 (2018)2026
Class I recalls in this family
- K211616 ExcelsiusHub2 generations on · 2021
Most influential descendants
Showing 5 of 191 · See all- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 2 generations on97descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 3 generations on84descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 2 generations on83descendants
- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc. · 2017 · cites it directly55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −9 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −8 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −5 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −4 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −2 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| −1 | K122097 | Patriot Spacers | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K140411 | Altera Spacer | Globus Medical, Inc. | 2014 | — |
| +1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| +2 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +3 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +2 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +1 | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy 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 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 10 | 0 |
| 2021 | 16 | 1 |
| 2022 | 19 | 0 |
| 2023 | 27 | 0 |
| 2024 | 40 | 0 |
| 2025 | 38 | 0 |
| 2026 | 29 | 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? (4)
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 |
|---|---|---|---|
| * | K102293 | Caliber Spacer | 2011 |
| * | K072970 | Patriot SpacersSummary page 1…Product Code: MAX Regulatory Class: 11,Panel Code: 87 Predicate(s): CALIBER® Spacer (K1I02293) PATRIOT®'Spacer (K072970 & K122097) CoAlign Innovation AccuL-IFO TL Cage (K1 13465) Purpose: The purpose of this submission is to re… | 2008 |
| * | K122097 | Patriot SpacersSummary page 1…oduct Code: MAX Regulatory Class: 11,Panel Code: 87 Predicate(s): CALIBER® Spacer (K1I02293) PATRIOT®'Spacer (K072970 & K122097) CoAlign Innovation AccuL-IFO TL Cage (K1 13465) Purpose: The purpose of this submission is to request clea… | 2012 |
| * | K113465 | Acculif TL CageSummary page 1…: 87 Predicate(s): CALIBER® Spacer (K1I02293) PATRIOT®'Spacer (K072970 & K122097) CoAlign Innovation AccuL-IFO TL Cage (K1 13465) Purpose: The purpose of this submission is to request clearance for the ALTERATM Spacer. Device Description: The ALTERA TM Spa… | 2011 |
What descends from it? (191)
See all 1918 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | 2019 | 42 |
| K192115 | SABLE Expandable Spacer | 2020 | 37 |
| K201024 | Expandable Titanium PLIF/TLIF System | 2021 | 5 |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | 2023 | 2 |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | 2023 | 2 |
| K243668 | ProLift Pivot Expandable Spacer System | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2020 | Class II | Z-2870-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2852-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2855-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2860-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2857-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2853-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2863-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2851-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2871-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2866-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2864-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2854-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2859-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2862-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2861-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2850-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2869-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2865-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2867-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2868-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2858-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Jul 22, 2020 | Class II | Z-2856-2020 | Nonconforming Material/Component | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
The 5 latest of 22 recalls; the web page lists all.
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 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K152022 (Globus Medical, Inc., 2017) has gone furthest, with 149 descendants of its own.
- 30 other devices also cite its predicate K102293.
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. 2014, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2007high 76 (2017) · low 7 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
2007high 137 (2010) · low 69 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
2007high 11 (2012) · low 0 (2007)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
2007high 811 (2025) · low 12 (2007)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 ALTERA 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 (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).
The ALTERA Spacer is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140411: Altera Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140411
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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