510(k) · Cleared
ClearedLumbar Expandable lnterbody Spacers -Additional Indications/Implants
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 Aug 3, 2023 as substantially equivalent to K191391 (Globus Medical, Inc., 2019) and 14 other predicates after a 399-day review. Its family tree reaches back 25 generations to 1984. 1 of the 528 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Aug 3, 2023
- Review
- 399 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 25 generations to K841189 (1984). 525 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 528 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- This deviceK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253401 SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK234035 COSINE™ SpacerGlobus Medical, Inc. · 2024
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- This deviceK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −1 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| 0 (this device) | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023 | — |
| +1 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026 | — |
| +1 | K234035 | COSINE™ Spacer | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 22 | 0 |
| 2004 | 41 | 0 |
| 2005 | 28 | 0 |
| 2006 | 15 | 0 |
| 2007 | 20 | 0 |
| 2008 | 51 | 1 |
| 2009 | 39 | 0 |
| 2010 | 29 | 0 |
| 2011 | 45 | 0 |
| 2012 | 31 | 0 |
| 2013 | 33 | 0 |
| 2014 | 31 | 0 |
| 2015 | 28 | 0 |
| 2016 | 17 | 0 |
| 2017 | 12 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (15)
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 |
|---|---|---|---|
| * | K191391 | HEDRON Lumbar SpacersSummary page 10…rtebral Body Fusion Device Product Code(s): MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: HEDRON® Lumbar Spacers (K191391) Other Predicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS®… | 2019 |
| * | K102293 | Caliber SpacerSummary page 10…Product Code(s): MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: HEDRON® Lumbar Spacers (K191391) Other Predicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® S… | 2011 |
| * | K123231 | Caliber SpacersSummary page 10…ode(s): MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: HEDRON® Lumbar Spacers (K191391) Other Predicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K1… | 2013 |
| * | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Summary page 10…AX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: HEDRON® Lumbar Spacers (K191391) Other Predicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K140411, K1… | 2017 |
| * | K113447 | Rise SpacerSummary page 10…s: II, Panel Code: 87 Primary Predicate: HEDRON® Lumbar Spacers (K191391) Other Predicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K140411, K171848) MAGNIFY® Spacer… | 2012 |
| * | K123913 | Latis SpacerSummary page 10…HEDRON® Lumbar Spacers (K191391) Other Predicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K140411, K171848) MAGNIFY® Spacer (K142498, K203278) SABLE… | 2013 |
| * | K140411 | Altera SpacerSummary page 10…dicates: CALIBER® Spacer (K102293, K123231, K171848) RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K140411, K171848) MAGNIFY® Spacer (K142498, K203278) SABLE® Expandable Spacer (K192115)… | 2014 |
| * | K142498 | MAGNIFY and MAGNIFY-S SpacersSummary page 10…RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K140411, K171848) MAGNIFY® Spacer (K142498, K203278) SABLE® Expandable Spacer (K192115) MONUMENT® Spacers (K132559, K203278)… | 2015 |
| * | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Summary page 10…RISE® Spacer (K113447) LATIS® Spacer (K123913) ALTERA® Spacer (K140411, K171848) MAGNIFY® Spacer (K142498, K203278) SABLE® Expandable Spacer (K192115) MONUMENT® Spacers (K132559, K203278) To… | 2021 |
| * | K192115 | SABLE Expandable SpacerSummary page 10…IS® Spacer (K123913) ALTERA® Spacer (K140411, K171848) MAGNIFY® Spacer (K142498, K203278) SABLE® Expandable Spacer (K192115) MONUMENT® Spacers (K132559, K203278) Toro-L Interbody Fusion System (K203038, K213355)… | 2020 |
| * | K132559 | Monument SpacersSummary page 10…Spacer (K140411, K171848) MAGNIFY® Spacer (K142498, K203278) SABLE® Expandable Spacer (K192115) MONUMENT® Spacers (K132559, K203278) Toro-L Interbody Fusion System (K203038, K213355) NuVasive Modulus Expandable Poste… | 2013 |
| * | K203038 | Toro-L Interbody Fusion SystemSummary page 10…8, K203278) SABLE® Expandable Spacer (K192115) MONUMENT® Spacers (K132559, K203278) Toro-L Interbody Fusion System (K203038, K213355) NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody Spacer (K210214)… | 2021 |
| * | K213355 | Toro-L Interbody Fusion SystemSummary page 10…8) SABLE® Expandable Spacer (K192115) MONUMENT® Spacers (K132559, K203278) Toro-L Interbody Fusion System (K203038, K213355) NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody Spacer (K210214)… | 2022 |
| * | K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemSummary page 10…Toro-L Interbody Fusion System (K203038, K213355) NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody Spacer (K210214) NuVasive MOD-EX XLIF Interbody System (K210439)… | 2021 |
| * | K210439 | NuVasive MOD-EX XLIF Interbody SystemSummary page 10…NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody Spacer (K210214) NuVasive MOD-EX XLIF Interbody System (K210439) K221894 - Page 2 of 6 Purpose: The purpos… | 2021 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 58 of the 525 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253401 (Globus Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K191391.
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. 2023, 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 at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion…
Read the full statement (1,096 words)
CALIBER® Spacers are interbody fusion devices intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK spacers.
CALIBER® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The RISE® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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.
The RISE® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
LATIS® Spacers are interbody fusion devices intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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.
LATIS® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The ALTERA® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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.
The ALTERA® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The MAGNIFY® Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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.
The MAGNIFY® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
SABLE® Expandable Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 2 spondylolisthesis or retrolisthesis at the involved level(s). 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. All MONUMENT® TPS coated spacers are indicated for the same use as non-coated spacers.
The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
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/K221894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221894
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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