510(k) · Cleared
ClearedXY Cor Spinal Implant for Minimal Invasive Spinal Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebration,Inc · MQP Spinal Vertebral Body Replacement Device
Cleared on Apr 20, 2007 as substantially equivalent to K031672 (Spinal Concepts, Inc., 2003) and 3 other predicates after a 101-day review. Its family tree reaches back 3 generations to 1984. 1 of the 651 devices in its family, counting itself, has a Class I recall. 641 later devices descend from it.
- Decided
- Apr 20, 2007
- Review
- 101 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K841189 (1984). 9 ancestors in all. 641 later devices descend from it, 2 citing it directly. 1 of the 651 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 2 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 1 generation backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
- This deviceK070082 XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc · 2007
- Descendant · cites it directly · 639 of its ownK090566 Pathway AvidCustom Spine, Inc. · 2009
- Descendant · 2 generations on · 601 of its ownK112359 Prow FusionNlt Spine, Ltd. · 2011
- Descendant · 3 generations on · 593 of its ownK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
- Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 5 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 641 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 641 · See all- K090566Pathway AvidCustom Spine, Inc. · 2009 · cites it directly639descendants
- K112359Prow FusionNlt Spine, Ltd. · 2011 · 2 generations on601descendants
- K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013 · 3 generations on593descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 5 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −2 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −1 | K003836 | Synthes Synex Spacer System | Synthes | 2001 | 11 |
| 0 (this device) | K070082 | XY Cor Spinal Implant for Minimal Invasive Spinal Surgery | Vertebration,Inc | 2007 | — |
| +1 | K090566 | Pathway Avid | Custom Spine, Inc. | 2009 | — |
| +2 | K112359 | Prow Fusion | Nlt Spine, Ltd. | 2011 | — |
| +3 | K130820 | Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2013 | — |
| +4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +5 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 25 | 0 |
| 2017 | 31 | 0 |
| 2018 | 36 | 0 |
| 2019 | 48 | 0 |
| 2020 | 66 | 0 |
| 2021 | 54 | 1 |
| 2022 | 63 | 0 |
| 2023 | 78 | 0 |
| 2024 | 83 | 0 |
| 2025 | 73 | 0 |
| 2026 | 61 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K031672 | Spinal Concepts, Inc. Infix SystemSummary page 1…ly Marketed Predicate Device The XYcorTM Spinal Implant is substantially equivalent to the InFix® System marketed by Abbott Spine, 5 10(k) Premarket Notification Number: K031672, FDA Product Code MQP. Secondly, it is substantially equivalent to the SYNEXTM System manufactured by Synthes Spine, 510(k) Prema… | 2003 |
| * | K010530 | Geo StructureSummary page 2…of Substantial Equivalence The XYcorTMSpinal Implant is substantially equivalent to INFIX® System manufactured by Abbott Spine under 510(k) Premarket Notification Number K010530, FDA Product Code MQP, and regulation 21CFR§888.3060 (spinal intervertebral body fixation orthosis) in material, intended use, ba… | 2001 |
| * | K003836 | Synthes Synex Spacer SystemSummary page 1…umber: K031672, FDA Product Code MQP. Secondly, it is substantially equivalent to the SYNEXTM System manufactured by Synthes Spine, 510(k) Premarket Notification Number: K003836, FDA Product Code MQP; and, to the DEVEXTM System manufactured by DePuy Spine; 510(k) Premarket Notification Number: K023835, FDA… | 2001 |
| * | K023835 | Devex Mesh SystemSummary page 1…Spine, 510(k) Premarket Notification Number: K003836, FDA Product Code MQP; and, to the DEVEXTM System manufactured by DePuy Spine; 510(k) Premarket Notification Number: K023835, FDA Product Code MQP. General Description The XYcorTM Spinal Implant is a vertebral body replacement device fabricated from ti… | 2003 |
What descends from it? (641)
See all 6412 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K090566 (Custom Spine, Inc., 2009) has gone furthest, with 639 descendants of its own.
- 5 other devices also cite its predicate K031672.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The XYcorTM Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcorTM Spinal implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column…
Read the full statement (159 words)
The XYcorTM Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcorTM Spinal implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The XYcorTM Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the XYcorTM Spinal Implant include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070082: XY Cor Spinal Implant for Minimal Invasive Spinal Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070082
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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