510(k) · Cleared
ClearedInterpore Cross International Anterior Fixation Device (Afd)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jan 23, 2003 after a 205-day review. The FDA summary names its predicate without a number. 1 of the 969 devices in its family, counting itself, has a Class I recall. 968 later devices descend from it.
- Decided
- Jan 23, 2003
- Review
- 205 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
968 later devices descend from it, 3 citing it directly. 1 of the 969 devices in this family, counting this one, has a Class I recall.
- This deviceK022143 Interpore Cross International Anterior Fixation Device (Afd)Interpore Cross Intl. · 2003
- Descendant · cites it directly · 862 of its ownK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
- Descendant · cites it directly · 834 of its ownK081501 Solitaire Anterior Spinal SystemBiomet Spine · 2008 · Recalled
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 3 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 641 of its ownK070082 XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc · 2007
Showing 5 of 968 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 968 · See all- K031672Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003 · cites it directly862descendants
- K081501Solitaire Anterior Spinal SystemBiomet Spine · 2008 · cites it directly834descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 3 generations on696descendants
- K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc · 2007 · 2 generations on641descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022143 | Interpore Cross International Anterior Fixation Device (Afd) | Interpore Cross Intl. | 2003 | — |
| +1 | K031672 | Spinal Concepts, Inc. Infix System | Spinal Concepts, Inc. | 2003 | — |
| +1 | K081501 | Solitaire Anterior Spinal System | Biomet Spine | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +2 | K070082 | XY Cor Spinal Implant for Minimal Invasive Spinal Surgery | Vertebration,Inc | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 25 | 0 |
| 2015 | 31 | 0 |
| 2016 | 53 | 0 |
| 2017 | 75 | 0 |
| 2018 | 74 | 0 |
| 2019 | 79 | 0 |
| 2020 | 94 | 0 |
| 2021 | 79 | 1 |
| 2022 | 79 | 0 |
| 2023 | 98 | 0 |
| 2024 | 97 | 0 |
| 2025 | 80 | 0 |
| 2026 | 71 | 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? (1)
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 |
|---|---|---|---|
| * | — | GEO Structure Named without a submission number |
What descends from it? (968)
See all 9683 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?
- Of its descendants, K031672 (Spinal Concepts, Inc., 2003) has gone furthest, with 862 descendants of its own.
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 Interpore Cross International AFD is indicated for use in the thoracolumbar spine @e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Interpore Cross International AFD is also indicated for treating fractures of the thoracic and lumbar spine. The Interpore Cross International AFD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fhion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022143 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022143: Interpore Cross International Anterior Fixation Device (Afd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022143
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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