510(k) · Cleared
ClearedCaliber 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 Jan 18, 2013 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 2 other predicates after a 94-day review. Its family tree reaches back 12 generations to 1984. 1 of the 680 devices in its family, counting itself, has a Class I recall. 657 later devices descend from it.
- Decided
- Jan 18, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K841189 (1984). 22 ancestors in all. 657 later devices descend from it, 24 citing it directly. 1 of the 680 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 1 generation backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- This deviceK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- Descendant · 4 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 4 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 1 generation backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- This deviceK123231 Caliber SpacersGlobus Medical, Inc. · 2013
Showing 5 of 657 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 657 · See all- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 2 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 3 generations on400descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 4 generations on396descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −8 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −4 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −3 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −2 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −1 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K123231 | Caliber Spacers | Globus Medical, Inc. | 2013 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +3 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| +4 | K160051 | NuVasive® Interfixated Interbody System | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 24 | 0 |
| 2017 | 35 | 0 |
| 2018 | 41 | 0 |
| 2019 | 50 | 0 |
| 2020 | 70 | 0 |
| 2021 | 59 | 1 |
| 2022 | 66 | 0 |
| 2023 | 79 | 0 |
| 2024 | 85 | 0 |
| 2025 | 76 | 0 |
| 2026 | 64 | 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? (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 |
|---|---|---|---|
| * | K102293 | Caliber SpacerSummary page 1…usion Devices. Product Code: MAX. Regulatory Class 11,Panel Code: 87. Predicate(s): CALIBER® Spacers (Ki102293) RISETM Spacers (K1 13447) Kiscomedica L-Varlock Tm Lumbar Cages (K080537)… | 2011 |
| * | K113447 | Rise SpacerSummary page 1…de: MAX. Regulatory Class 11,Panel Code: 87. Predicate(s): CALIBER® Spacers (Ki102293) RISETM Spacers (K1 13447) Kiscomedica L-Varlock Tm Lumbar Cages (K080537) Purpose: The purpose of this sub… | 2012 |
| * | K080537 | L-VarlockSummary page 1…Predicate(s): CALIBER® Spacers (Ki102293) RISETM Spacers (K1 13447) Kiscomedica L-Varlock Tm Lumbar Cages (K080537) Purpose: The purpose of this submission is to request clearance for additional spacers with lordo… | 2008 |
What descends from it? (657)
See all 65724 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141665 | NuVasive CoRoent System | 2015 | 588 |
| K143595 | NuVasive (R) CCX-L Interbody System | 2015 | 253 |
| K153627 | NuVasive® TLX Interbody System | 2016 | 252 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K142498 | MAGNIFY and MAGNIFY-S Spacers | 2015 | 175 |
| K161379 | ELSA Spacers | 2016 | 155 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K151665 | SUSTAIN Additional Implants | 2016 | 119 |
| K152011 | Lucent Intervertebral Body Fusion Device | 2016 | 106 |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | 2018 | 97 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K141665 (Nuvasive, Inc., 2015) has gone furthest, with 588 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. 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?
CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease. (DOD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDID 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…
Read the full statement (107 words)
CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease. (DOD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDID 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).
CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123231: Caliber Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123231
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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