510(k) · Cleared
ClearedXYcor® Expandable Spinal Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 24, 2016 as substantially equivalent to K080699 (Alphatec Spine, Inc., 2008) and 2 other predicates after a 170-day review. Its family tree reaches back 12 generations to 1984. 41 later devices descend from it.
- Decided
- Aug 24, 2016
- Review
- 170 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K841189 (1984). 40 ancestors in all. 41 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
- 1 generation backK123913 Latis SpacerGlobus Medical, Inc. · 2013
- This deviceK160646 XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc. · 2016
- Descendant · cites it directly · 39 of its ownK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 38 of its ownK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 3 generations on · 13 of its ownK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 4 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
- 1 generation backK123913 Latis SpacerGlobus Medical, Inc. · 2013
- This deviceK160646 XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc. · 2016
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020 · cites it directly39descendants
- K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc. · 2021 · 2 generations on38descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
- K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc. · 2022 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −8 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −4 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −3 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −2 | K102313 | Patriot Transcontinental M Spacers | Globus Medical, Inc. | 2010 | — |
| −1 | K123913 | Latis Spacer | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K160646 | XYcor® Expandable Spinal Spacer System | Alphatec Spine, Inc. | 2016 | — |
| +1 | K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
| +3 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +3 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti… | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080699 | Novel Spinal Spacer SystemSummary page 4…al intervertebral body fixation device Class: II Product Codes: MAX, MQP Primary Predicate Device: Alphatec Spine Novel Spinal Spacer System (K080699) Additional Predicates: Vertebration XYcor Spinal Implant (K082466) Globus Medical LATIS S… | 2008 |
| * | K082466 | Xycor Spinal ImplantSummary page 4…es: MAX, MQP Primary Predicate Device: Alphatec Spine Novel Spinal Spacer System (K080699) Additional Predicates: Vertebration XYcor Spinal Implant (K082466) Globus Medical LATIS Spacers (K123913) Indications for Use: When used as an Intervertebral Body… | 2009 |
| * | K123913 | Latis SpacerSummary page 4…el Spinal Spacer System (K080699) Additional Predicates: Vertebration XYcor Spinal Implant (K082466) Globus Medical LATIS Spacers (K123913) Indications for Use: When used as an Intervertebral Body Fusion device, the XYcor Expandable Spinal Spacer System is indicated… | 2013 |
| Kept off the family tree | K082644 | FDA’s K082644 is Glidesheath Our reading of the summary gave K082644, FDA’s number for Glidesheath (Terumo Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “XYcor Spinal System”. Kept off the family tree. Summary page 5…The subject XYcor Expandable Spinal Spacer System is substantially equivalent to the predicate Alphatec Spine Novel Spinal Spacer System (K080699), XYcor Spinal System (K082644), and the Globus Medical LATIS Spacers (K123913) with respect to technological characteristics of indications, design, materials,… | 2008 |
What descends from it? (41)
See all 412 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 40 ancestors have a recall of any class.
- Of its descendants, K202587 (Alphatec Spine, Inc., 2020) has gone furthest, with 39 descendants of its own.
- 10 other devices also cite its predicate K080699.
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?
When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis…
Read the full statement (211 words)
When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
When used as a Vertebral Body Replacement device, the XYcor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The XYcor Expandable Spinal Spacer System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
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/K160646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160646: XYcor® Expandable Spinal Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160646
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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