510(k) · Cleared
ClearedINDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA 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 Feb 2, 2021 as substantially equivalent to K201087 (Globus Medical, Inc., 2020) and 14 other predicates after an 88-day review. Its family tree reaches back 24 generations to 1984. 1 of the 490 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.
- Decided
- Feb 2, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 24 generations to K841189 (1984). 454 ancestors in all, the oldest K792352 (1979). 35 later devices descend from it, 8 citing it directly. 1 of the 490 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 1 generation backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- This deviceK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- Descendant · cites it directly · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
- Descendant · 2 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- Descendant · 2 generations on · 5 of its ownK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
- Descendant · 2 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 5 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 4 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 1 generation backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- This deviceK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 35 · See all- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · cites it directly23descendants
- K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022 · cites it directly7descendants
- K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 2 generations on6descendants
- K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 2 generations on5descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −5 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −1 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| 0 (this device) | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| +1 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +1 | K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2022 | — |
| +2 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
| +2 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | — |
| +2 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
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 | 40 | 0 |
| 2005 | 27 | 0 |
| 2006 | 15 | 0 |
| 2007 | 20 | 0 |
| 2008 | 50 | 1 |
| 2009 | 35 | 0 |
| 2010 | 26 | 0 |
| 2011 | 34 | 0 |
| 2012 | 23 | 0 |
| 2013 | 27 | 0 |
| 2014 | 21 | 0 |
| 2015 | 20 | 0 |
| 2016 | 12 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K201087 | CORBEL SpacersSummary page 9…Intervertebral Body Fusion Device Product Code(s): MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: CORBEL™ Spacers (K201087) Other Predicates: INDEPENDENCE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597)… | 2020 |
| * | K082252 | Independence SpacerSummary page 9…Product Code(s): MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: CORBEL™ Spacers (K201087) Other Predicates: INDEPENDENCE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157… | 2008 |
| * | K120101 | Independence SpacerSummary page 9…Code(s): MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: CORBEL™ Spacers (K201087) Other Predicates: INDEPENDENCE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157)… | 2012 |
| * | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Summary page 9…MAX, OVD Regulatory Class: II, Panel Code: 87 Primary Predicate: CORBEL™ Spacers (K201087) Other Predicates: INDEPENDENCE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157)… | 2017 |
| * | K160597 | INDEPENDENCE MIS SpacersSummary page 9…Code: 87 Primary Predicate: CORBEL™ Spacers (K201087) Other Predicates: INDEPENDENCE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157) HEDRON™ Lumbar Spacers (K191391) M… | 2016 |
| * | K170157 | INDEPENDENCE® SpacersSummary page 9…ther Predicates: INDEPENDENCE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157) HEDRON™ Lumbar Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Sp… | 2017 |
| * | K191391 | HEDRON Lumbar SpacersSummary page 9…20101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157) HEDRON™ Lumbar Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Spacers (K132559) InterContinental®… | 2019 |
| * | K142498 | MAGNIFY and MAGNIFY-S SpacersSummary page 9…MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157) HEDRON™ Lumbar Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223, K171848)… | 2015 |
| * | K132559 | Monument SpacersSummary page 9…ENDENCE MIS AGX™ Spacers (K170157) HEDRON™ Lumbar Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223, K171848) ELSA® Spacers (K161379)… | 2013 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 9…™ Lumbar Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223, K171848) ELSA® Spacers (K161379) LDR Avenue-L Lateral Lumbar Cage (K153495)… | 2011 |
| * | K161223 | TransContinental® M Spacers and InterContinental® Plate-SpacersSummary page 9…Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223, K171848) ELSA® Spacers (K161379) LDR Avenue-L Lateral Lumbar Cage (K153495)… | 2016 |
| * | K161379 | ELSA SpacersSummary page 9…ers (K142498) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223, K171848) ELSA® Spacers (K161379) LDR Avenue-L Lateral Lumbar Cage (K153495) NuVasive Brigade Lateral System (K181386)… | 2016 |
| * | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Summary page 9…InterContinental® Plate-Spacer (K103382, K161223, K171848) ELSA® Spacers (K161379) LDR Avenue-L Lateral Lumbar Cage (K153495) NuVasive Brigade Lateral System (K181386) NuVasive CoRoent XL (K201820)… | 2016 |
| * | K181386 | NuVasive Brigade Lateral SystemSummary page 9…61223, K171848) ELSA® Spacers (K161379) LDR Avenue-L Lateral Lumbar Cage (K153495) NuVasive Brigade Lateral System (K181386) NuVasive CoRoent XL (K201820)… | 2018 |
| * | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Summary page 9…(K161379) LDR Avenue-L Lateral Lumbar Cage (K153495) NuVasive Brigade Lateral System (K181386) NuVasive CoRoent XL (K201820) K203278… | 2020 |
What descends from it? (35)
See all 358 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | 2022 | 23 |
| K212498 | Stable-L Standalone Lumbar Interbody System | 2022 | 7 |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | 2023 | 2 |
| K261408 | SABER-XA System | 2026 | 0 |
| K250599 | ExcelsiusGPS™ Instruments | 2025 | 0 |
| K234035 | COSINE™ Spacer | 2024 | 0 |
| K234077 | SPIRA® Anterior Lumbar Spacers | 2024 | 0 |
| K233735 | ADIRA™ Lateral Plate System | 2024 | 0 |
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 48 of the 454 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222270 (Globus Medical, Inc., 2022) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K201087.
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. 2021, 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?
INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices 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), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and…
Read the full statement (1,078 words)
INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices 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), 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 INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant.
INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.
All INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices 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), 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. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant. HEDRON IA™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The MAGNIFY®-S 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), 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®-S Spacer is to be used with or without three screws which accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when used with three screws per implant. The MAGNIFY®-S Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
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 1 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.
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.
InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices 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), 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 InterContinental® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
InterContinental® Plate-Spacers are intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). InterContinental® Plate-Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The ELSA® 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), 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 ELSA® Spacer is intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation. Hyperlordotic (>20°) implants must be used with the two screws and/or anchors and supplemental fixation in addition to the two screws and/or anchors. The ELSA® Spacer is to be filled with autograft and/or allogenic bone graft comprised 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/K203278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203278
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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