510(k) · Cleared
ClearedArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arftx Medical, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 6, 2022 as substantially equivalent to K192117 (Ulrich GmbH & Co. KG, 2019) after a 472-day review. Its family tree reaches back 16 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 6, 2022
- Review
- 472 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K841189 (1984). 64 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- 2 generations backK173982 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2018
- 1 generation backK192117 Small VBR™Ulrich GmbH & Co. KG · 2019
- This deviceK211892 ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC · 2022
- Descendant · cites it directly · 1 of its ownK252686 EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK260850 Osteomni Spinal Cages SystemOsteomni, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 10 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 9 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 8 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 7 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 6 generations backK121176 STGCCardinal Spine, LLC · 2012
- 5 generations backK142030 STGC-LordoticCardinal Spine, LLC · 2015
- 4 generations backK152568 C-VBRCardinal Spine, LLC · 2016
- 3 generations backK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- 2 generations backK173982 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2018
- 1 generation backK192117 Small VBR™Ulrich GmbH & Co. KG · 2019
- This deviceK211892 ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −10 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −9 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −8 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −7 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −6 | K121176 | STGC | Cardinal Spine, LLC | 2012 | — |
| −5 | K142030 | STGC-Lordotic | Cardinal Spine, LLC | 2015 | — |
| −4 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| −3 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| −2 | K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018 | — |
| −1 | K192117 | Small VBR™ | Ulrich GmbH & Co. KG | 2019 | — |
| 0 (this device) | K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | 2022 | — |
| +1 | K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025 | — |
| +2 | K260850 | Osteomni Spinal Cages System | Osteomni, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 MQP? 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 |
|---|---|---|---|
| * | K192117 | Small VBR™Summary page 6…BR REGULATION NUMBER: 21 CFR 888.3060 REGULATION NAME: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS REGULATORY CLASS: Class II PRODUCT CODE: MQP, PLR 510(K) NUMBER: K192117 CONCLUSION: The ARTFX CORPECTOMY CAGE has the same intended use and technological characteristics as the predicate device. Ther… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | 2025 | 1 |
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 38 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 64 ancestors have a recall of any class.
- Of its descendants, K252686 (Effortmed, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K192117.
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. 2022, 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 ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the…
Read the full statement (200 words)
The ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.
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/K211892 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211892: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211892
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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