510(k) · Cleared
ClearedSpinal Concepts, Inc. Infix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 7, 2003 as substantially equivalent to K010530 (Interpore Cross Intl., 2001) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 2001. 1 of the 866 devices in its family, counting itself, has a Class I recall. 862 later devices descend from it.
- Decided
- Aug 7, 2003
- Review
- 69 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010530 (2001). 3 ancestors in all. 862 later devices descend from it, 6 citing it directly. 1 of the 866 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 1 generation backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- This deviceK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
- Descendant · cites it directly · 641 of its ownK070082 XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc · 2007
- Descendant · 2 generations on · 639 of its ownK090566 Pathway AvidCustom Spine, Inc. · 2009
- Descendant · 3 generations on · 601 of its ownK112359 Prow FusionNlt Spine, Ltd. · 2011
- Descendant · 4 generations on · 593 of its ownK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
- Descendant · 5 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
Showing 5 of 862 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 862 · See all- K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc · 2007 · cites it directly641descendants
- K090566Pathway AvidCustom Spine, Inc. · 2009 · 2 generations on639descendants
- K112359Prow FusionNlt Spine, Ltd. · 2011 · 3 generations on601descendants
- K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013 · 4 generations on593descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 5 generations on588descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −1 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| 0 (this device) | K031672 | Spinal Concepts, Inc. Infix System | Spinal Concepts, Inc. | 2003 | — |
| +1 | K070082 | XY Cor Spinal Implant for Minimal Invasive Spinal Surgery | Vertebration,Inc | 2007 | — |
| +2 | K090566 | Pathway Avid | Custom Spine, Inc. | 2009 | — |
| +3 | K112359 | Prow Fusion | Nlt Spine, Ltd. | 2011 | — |
| +4 | K130820 | Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2013 | — |
| +5 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 16 | 0 |
| 2015 | 18 | 0 |
| 2016 | 41 | 0 |
| 2017 | 63 | 0 |
| 2018 | 63 | 0 |
| 2019 | 70 | 0 |
| 2020 | 87 | 0 |
| 2021 | 75 | 1 |
| 2022 | 78 | 0 |
| 2023 | 95 | 0 |
| 2024 | 94 | 0 |
| 2025 | 78 | 0 |
| 2026 | 69 | 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? (3)
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 |
|---|---|---|---|
| * | K010530 | Geo StructureSummary page 1…MQP Predicate Devices: InFixO is substantially equivalent to the Interpore Cross GEOTMStructure, which was cleared as an oval shaped configuration on August 3,2001 (K010530) and as a rectangular shaped configuration on February 6,2002 (K020048) and Interpore Cross International Anterior Fixation Devic… | 2001 |
| * | K020048 | Modification to Geo StructureSummary page 1…nterpore Cross GEOTMStructure, which was cleared as an oval shaped configuration on August 3,2001 (K010530) and as a rectangular shaped configuration on February 6,2002 (K020048) and Interpore Cross International Anterior Fixation Device (AFD) cleared on January 23,2003 (KO22 143). Device Description: InF… | 2002 |
| * | K022143 | Interpore Cross International Anterior Fixation Device (Afd) | 2003 |
What descends from it? (862)
See all 8626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070082 | XY Cor Spinal Implant for Minimal Invasive Spinal Surgery | 2007 | 641 |
| K130699 | Aleutian Spinal System | 2013 | 570 |
| K083894 | Alif Spinal Truss Interbody Fusion Device | 2011 | 538 |
| K083714 | Endoskeleton TT Interbody Fusion Device (Ibd) | 2009 | 412 |
| K132790 | Infix Anterior Lumbar System | 2013 | 28 |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody… | 2015 | 19 |
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070082 (Vertebration,Inc, 2007) has gone furthest, with 641 descendants of its own.
- 9 other devices also cite its predicate K010530.
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.
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 InFix System is 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).
InFix 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 InFix is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031672: Spinal Concepts, Inc. Infix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031672
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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