510(k) · Cleared
ClearedINDEPENDENCE® 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 Sep 25, 2017 as substantially equivalent to K160597 (Globus Medical, Inc., 2016) and 5 other predicates after a 250-day review. Its family tree reaches back 18 generations to 1984. 109 later devices descend from it.
- Decided
- Sep 25, 2017
- Review
- 250 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 18 generations to K841189 (1984). 169 ancestors in all, the oldest K792352 (1979). 109 later devices descend from it, 6 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK160597 INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
- This deviceK170157 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 · 2 generations on · 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
- Descendant · 2 generations on · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 5 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 4 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK160597 INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
- This deviceK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- 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 · 2 generations on36descendants
- K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc. · 2021 · cites it directly35descendants
- K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −5 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −2 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −1 | K160597 | INDEPENDENCE MIS Spacers | Globus Medical, Inc. | 2016 | — |
| 0 (this device) | 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 | — |
| +2 | K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 | — |
| +1 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| +2 | K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 22 | 0 |
| 2005 | 14 | 0 |
| 2006 | 9 | 0 |
| 2007 | 10 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160597 | INDEPENDENCE MIS SpacersSummary page 5…ody Fusion Device Product Code(s): OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® MIS Spacers (K160597) Additional INDEPENDENCE® Spacers (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K14239… | 2016 |
| * | K082252 | Independence SpacerSummary page 5…: OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® MIS Spacers (K160597) Additional INDEPENDENCE® Spacers (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K142397) TPS Spacers (K143578)… | 2008 |
| * | K120101 | Independence SpacerSummary page 5…X Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® MIS Spacers (K160597) Additional INDEPENDENCE® Spacers (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K142397) TPS Spacers (K143578)… | 2012 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 5…Primary Predicate: INDEPENDENCE® MIS Spacers (K160597) Additional INDEPENDENCE® Spacers (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K142397) TPS Spacers (K143578) MAGNIFY Spacers (K142498) Reference Device: COALITION®… | 1996 |
| Kept off the family tree | K142397 | FDA’s K142397 is Predicate III Guidewire Our reading of the summary gave K142397, FDA’s number for Predicate III Guidewire (Lake Region Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “BAK INTERBODY FUSION SYSTEM”. Kept off the family tree. Summary page 5…Predicate: INDEPENDENCE® MIS Spacers (K160597) Additional INDEPENDENCE® Spacers (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K142397) TPS Spacers (K143578) MAGNIFY Spacers (K142498) Reference Device: COALITION® AGX (K14… | 2014 |
| * | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Summary page 5…597) Additional INDEPENDENCE® Spacers (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K142397) TPS Spacers (K143578) MAGNIFY Spacers (K142498) Reference Device: COALITION® AGX (K142218) Purpose: The purpose of this submiss… | 2016 |
| * | K142498 | MAGNIFY and MAGNIFY-S SpacersSummary page 5…s (K082252, K120101) Predicates: BAK INTERBODY FUSION SYSTEM (P950002, K142397) TPS Spacers (K143578) MAGNIFY Spacers (K142498) Reference Device: COALITION® AGX (K142218) Purpose: The purpose of this submission is to request clearance for the following i… | 2015 |
| † | K142218 | Coalition AGX Plate and Coalition AGX Spacer | 2015 |
What descends from it? (109)
See all 1096 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191391 | HEDRON Lumbar Spacers | 2019 | 84 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental… | 2021 | 35 |
| K201585 | Monterey AL Interbody System | 2020 | 4 |
| K230731 | Zavation ALIF System | 2023 | 2 |
| K203207 | Omnia Medical TiBrid-SA | 2020 | 1 |
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 33 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 169 ancestors have a recall of any class.
- Of its descendants, K191391 (Globus Medical, Inc., 2019) has gone furthest, with 84 descendants of its own.
- 7 other devices also cite its predicate K160597.
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. 2017, 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® TPS, INDEPENDENCE MIS™, INDEPENDENCE MIS™ TPS, INDEPENDENCE MIS AGX™, and INDEPENDENCE MIS AGX™ TPS) Spacers are 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…
Read the full statement (345 words)
INDEPENDENCE® (including INDEPENDENCE® TPS, INDEPENDENCE MIS™, INDEPENDENCE MIS™ TPS, INDEPENDENCE MIS AGX™, and INDEPENDENCE MIS AGX™ TPS) Spacers are 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 1 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.
INDEPENDENCE® and INDEPENDENCE® TPS Spacers are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.
INDEPENDENCE MIS™ and INDEPENDENCE MIS™ TPS Spacers are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are 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).
INDEPENDENCE MIS AGX™ Integrated Spacer, INDEPENDENCE MIS AGX™ TPS Integrated Spacer, and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are 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).
INDEPENDENCE MIS AGX™ Spacer and INDEPENDENCE MIS AGX™ TPS Spacer 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.
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/K170157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170157: INDEPENDENCE® Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170157
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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