510(k) · Cleared
ClearedINDEPENDENCE MIS Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Aug 29, 2016 as substantially equivalent to K082252 (Globus Medical, Inc., 2008) and 4 other predicates after a 180-day review. Its family tree reaches back 17 generations to 1984. 111 later devices descend from it.
- Decided
- Aug 29, 2016
- Review
- 180 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 113 ancestors in all. 111 later devices descend from it, 8 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- This deviceK160597 INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 109 of its ownK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 55 of its ownK171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 36 of its ownK201087 CORBEL SpacersGlobus Medical, Inc. · 2020
- Descendant · cites it directly · 35 of its ownK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 4 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- This deviceK160597 INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017 · cites it directly109descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · cites it directly84descendants
- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc. · 2017 · cites it directly55descendants
- K201087CORBEL SpacersGlobus Medical, Inc. · 2020 · cites it directly36descendants
- K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc. · 2021 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −4 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −3 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −1 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| 0 (this device) | K160597 | INDEPENDENCE MIS Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017 | — |
| +1 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers… | Globus Medical, Inc. | 2017 | — |
| +1 | K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 | — |
| +1 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 13 | 0 |
| 2005 | 11 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 13 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 11 | 0 |
| 2023 | 16 | 0 |
| 2024 | 31 | 0 |
| 2025 | 21 | 0 |
| 2026 | 17 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K082252 | Independence SpacerSummary page 4…bral Body Fusion Device Product Code(s): OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® Spacers (K082252) Additional INDEPENDENCE® Spacers (K120101) Predicates: ROI-A Implant System (K110327) STAL… | 2008 |
| * | K120101 | Independence SpacerSummary page 4…ode(s): OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® Spacers (K082252) Additional INDEPENDENCE® Spacers (K120101) Predicates: ROI-A Implant System (K110327) STALIF TT (K150643) Brigade Hyperlord… | 2012 |
| * | K110327 | LDR Spine Roi-a Interbody Fusion SystemSummary page 4…ss: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® Spacers (K082252) Additional INDEPENDENCE® Spacers (K120101) Predicates: ROI-A Implant System (K110327) STALIF TT (K150643) Brigade Hyperlordotic System (K123045) Purpose: The purpose of this… | 2011 |
| * | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiSummary page 4…e: INDEPENDENCE® Spacers (K082252) Additional INDEPENDENCE® Spacers (K120101) Predicates: ROI-A Implant System (K110327) STALIF TT (K150643) Brigade Hyperlordotic System (K123045) Purpose: The purpose of this submission is to request clearance for… | 2015 |
| * | K123045 | Brigade Standalone SystemSummary page 4…EPENDENCE® Spacers (K120101) Predicates: ROI-A Implant System (K110327) STALIF TT (K150643) Brigade Hyperlordotic System (K123045) Purpose: The purpose of this submission is to request clearance for additional INDEPENDENCE® MIS implants; and to update indica… | 2013 |
What descends from it? (111)
See all 1118 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170157 | INDEPENDENCE® Spacers | 2017 | 109 |
| K191391 | HEDRON Lumbar Spacers | 2019 | 84 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K201087 | CORBEL Spacers | 2020 | 36 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental… | 2021 | 35 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | 2025 | 1 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | 2025 | 0 |
| K210590 | Axis Spine Technologies ALIF | 2021 | 0 |
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 32 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 17 of the 113 ancestors have a recall of any class.
- Of its descendants, K170157 (Globus Medical, Inc., 2017) has gone furthest, with 109 descendants of its own.
- 12 other devices also cite its predicate K082252.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
INDEPENDENCE® (including INDEPENDENCE® MIS) Spacers interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-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…
Read the full statement (197 words)
INDEPENDENCE® (including INDEPENDENCE® MIS) Spacers interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-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 | spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant.
The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
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/K160597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160597: INDEPENDENCE MIS Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160597
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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