510(k) · Cleared
ClearedXsert Lumbar Expandable Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 17, 2016 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 3 other predicates after a 226-day review. Its family tree reaches back 19 generations to 1984. 12 later devices descend from it.
- Decided
- Nov 17, 2016
- Review
- 226 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 140 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK152651 AccuLIF TL and PL CageStryker Corporation · 2015
- This deviceK160959 Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc. · 2016
- Descendant · cites it directly · 11 of its ownK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 2 generations on · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 7 of its ownK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK152651 AccuLIF TL and PL CageStryker Corporation · 2015
- This deviceK160959 Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K211873PSX Interbody SystemAlphatec Spine, Inc. · 2021 · cites it directly11descendants
- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · 2 generations on8descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · 3 generations on7descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −1 | K152651 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | — |
| 0 (this device) | K160959 | Xsert Lumbar Expandable Interbody System | X-Spine Systems, Inc. | 2016 | — |
| +1 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +2 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
| +2 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
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 | 12 | 0 |
| 2004 | 18 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 18 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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.
Planning a device in MAX? 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? (4)
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 5…K160959 - Page 2 of 4 IV. PREDICATE DEVICES x Primary: Globus Medical Caliber Spacers (K102293) o This predicate has not been subject to a design related recall. x Additional: X-spine Calix Lumba… | 2011 |
| * | K131350 | Calix Lumbar Spinal Implant SystemSummary page 5…pacers (K102293) o This predicate has not been subject to a design related recall. x Additional: X-spine Calix Lumbar Spinal Implant System (K131350) o This predicate has not been subject to a design related recall. x Additional: Stryker AccuLIF®… | 2013 |
| * | K152651 | AccuLIF TL and PL CageSummary page 5…Implant System (K131350) o This predicate has not been subject to a design related recall. x Additional: Stryker AccuLIF® TL and PL Cage (K152651) o This predicate has not been subject to a design related recall. x Additional: Interventional Sp… | 2015 |
| * | K113527 | Opticage Interbody Fusion DeviceSummary page 5…51) o This predicate has not been subject to a design related recall. x Additional: Interventional Spine Opticage Interbody Fusion Device (K113527) o This predicate has not been subject to a design related recall. V. REFERENCE DEVICE X-s… | 2012 |
| † | K152132 | X-spine Pedicle Screw System | 2015 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211873 | PSX Interbody System | 2021 | 11 |
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 12 companies; a new generation was cleared every 10 months on median.
- 15 of the 140 ancestors have a recall of any class.
- Of its descendants, K211873 (Alphatec Spine, Inc., 2021) has gone furthest, with 11 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. 2016, 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?
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).…
Read the full statement (169 words)
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160959: Xsert Lumbar Expandable Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160959
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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