510(k) · Cleared
ClearedSANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Nov 28, 2018 as substantially equivalent to K162315 (Globus Medical, Inc., 2017) and 4 other predicates after a 259-day review. Its family tree reaches back 22 generations to 1984. 1 of the 257 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Nov 28, 2018
- Review
- 259 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K841189 (1984). 247 ancestors in all, the oldest K792352 (1979). 9 later devices descend from it, 5 citing it directly. 1 of the 257 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- 1 generation backK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- This deviceK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- Descendant · cites it directly · 2 of its ownK211320 CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · cites it directly · 1 of its ownK202637 F3D Corpectomy SystemCorelink, LLC · 2020
- Descendant · cites it directly · 1 of its ownK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
- Descendant · cites it directly · 1 of its ownK193412 NEXXT MATRIXX SystemNexxt Spine, LLC · 2020
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- 1 generation backK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- This deviceK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 9 · See all- K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022 · cites it directly2descendants
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · cites it directly1descendant
- K202637F3D Corpectomy SystemCorelink, LLC · 2020 · cites it directly1descendant
- K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020 · cites it directly1descendant
- K193412NEXXT MATRIXX SystemNexxt Spine, LLC · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −2 | K170055 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| −1 | K171704 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| 0 (this device) | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018 | — |
| +1 | K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022 | — |
| +1 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +1 | K202637 | F3D Corpectomy System | Corelink, LLC | 2020 | — |
| +1 | K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020 | — |
| +1 | K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 12 | 0 |
| 2008 | 36 | 1 |
| 2009 | 20 | 0 |
| 2010 | 9 | 0 |
| 2011 | 17 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K162315 | FORTIFY Corpectomy SpacersSummary page 7…lassification Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code PLR, MQP) Predicate Device(s) Primary Predicate: • Globus Fortfy (K162315) Additional Predicates: • K2M CAPRI Corpectomy Cage System (K170055) • Santorini Corpectomy Cage System (K171704) • Aesc… | 2017 |
| * | K170055 | CAPRI Corpectomy Cage SystemSummary page 7…CFR 888.3060, Product Code PLR, MQP) Predicate Device(s) Primary Predicate: • Globus Fortfy (K162315) Additional Predicates: • K2M CAPRI Corpectomy Cage System (K170055) • Santorini Corpectomy Cage System (K171704) • Aesculap Modulift (K172032) • Nuvasive X Core Mini (K151651) Device De… | 2017 |
| * | K171704 | CAPRI Corpectomy Cage SystemSummary page 7…e Device(s) Primary Predicate: • Globus Fortfy (K162315) Additional Predicates: • K2M CAPRI Corpectomy Cage System (K170055) • Santorini Corpectomy Cage System (K171704) • Aesculap Modulift (K172032) • Nuvasive X Core Mini (K151651) Device Description The SANTORINI and CAPRI Corpectomy Sys… | 2017 |
| * | K172032 | Modulift Vertebral Body Replacement (VBR) SystemSummary page 7…• Globus Fortfy (K162315) Additional Predicates: • K2M CAPRI Corpectomy Cage System (K170055) • Santorini Corpectomy Cage System (K171704) • Aesculap Modulift (K172032) • Nuvasive X Core Mini (K151651) Device Description The SANTORINI and CAPRI Corpectomy System implants are vertebral body r… | 2017 |
| * | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR SystemSummary page 7…l Predicates: • K2M CAPRI Corpectomy Cage System (K170055) • Santorini Corpectomy Cage System (K171704) • Aesculap Modulift (K172032) • Nuvasive X Core Mini (K151651) Device Description The SANTORINI and CAPRI Corpectomy System implants are vertebral body replacement devices that are designed… | 2015 |
What descends from it? (9)
5 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 29 of the 247 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211320 (K2m, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K162315.
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. 2018, 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?
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine. When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical…
Read the full statement (574 words)
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), SANTORINI cages are iniended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA
CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumer and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the CAPRI Static cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is 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/K180665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180665
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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