510(k) Report

510(k) · Cleared

Cleared

Santorini Spinal System

K111294510(k) TraditionalCleared Jan 27, 2012262-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Jan 27, 2012 as substantially equivalent to K060665 (Globus Medical, Inc., 2006) and 6 other predicates after a 262-day review. Its family tree reaches back 8 generations to 1984. 18 later devices descend from it.

Decided
Jan 27, 2012
Review
262 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
8

Its longest line of descent runs back 8 generations to K841189 (1984). 28 ancestors in all. 18 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 4 other ancestors2003: 3 other ancestors2001: 7 other ancestors2005: 1 other ancestor2002: 3 other ancestors2000: 1 other ancestor2014: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2020: 4 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2023: 3 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 2005K070381 · Theken VU Mesh VBR System · Theken Spine, LLC · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 8 other ancestors4 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants K070381 · Theken VU Mesh VBR System · Theken Spine, LLC · 2007K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 2005K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50
  1. Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 2 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
  8. 1 generation backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  9. This deviceK111294 Santorini Spinal SystemK2m, Inc. · 2012
  10. Descendant · cites it directly · 12 of its ownK142016 CAPRIK2m, Inc. · 2014
  11. Descendant · cites it directly · 11 of its ownK170055 CAPRI Corpectomy Cage SystemK2m · 2017
  12. Descendant · cites it directly · 10 of its ownK171704 CAPRI Corpectomy Cage SystemK2m · 2017
  13. Descendant · 2 generations on · 9 of its ownK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
  14. Descendant · cites it directly · 5 of its ownK151481 Sahara Stabilization SystemK2m, Inc. · 2015

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 32018: 12020: 42022: 12023: 32024: 12025: 12026: 2
2014high 4 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 18 · See all
  • K142016CAPRIK2m, Inc. · 2014 · cites it directly12descendants
  • K170055CAPRI Corpectomy Cage SystemK2m · 2017 · cites it directly11descendants
  • K171704CAPRI Corpectomy Cage SystemK2m · 2017 · cites it directly10descendants
  • K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018 · 2 generations on9descendants
  • K151481Sahara Stabilization SystemK2m, Inc. · 2015 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−7K990148Stackable Cage SystemDepuy Motech Acromed1999—
−6K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−5K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−4K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−3K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−2K050058Theken Reveal VBR SystemTheken Surgical,Llc2005—
−1K070381Theken VU Mesh VBR SystemTheken Spine, LLC2007—
0 (this device)K111294Santorini Spinal SystemK2m, Inc.2012—
+1K142016CAPRIK2m, Inc.2014—
+1K170055CAPRI Corpectomy Cage SystemK2m2017—
+1K171704CAPRI Corpectomy Cage SystemK2m2017—
+2K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC2018—
+1K151481Sahara Stabilization SystemK2m, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200170
200230
200330
200440
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201730
201810
202040
202210
202330
202410
202510
202620
FIG. 1 — Lineage of K111294, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK085454Aleutian Spacer System
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*K060665Xpand Radiolucent Corpectomy Spacer
Summary page 1
…Class 11 3. Predicate or legally marketed devices which are substantially equivalent * Aleutian Spacer System (KOS51454) * Globus Xpand-R ( K060665). * Medtronic Verte-stack (K030736) * OEC Rezaian (K84 1189) * DePuy Surgical Titanium Mesh (K003043) * Ost…
Globus Medical, Inc.2006—
*K030736Verte-Stack Spinal System, Extra Small Sizes
Summary page 1
…egally marketed devices which are substantially equivalent * Aleutian Spacer System (KOS51454) * Globus Xpand-R ( K060665). * Medtronic Verte-stack (K030736) * OEC Rezaian (K84 1189) * DePuy Surgical Titanium Mesh (K003043) * Osteotech VBR (003 155) * Theken VuMesh (…
Medtronic Sofamor Danek2003—
*K841189Oec/Rezaian Spinal Fixator
Summary page 1
…h are substantially equivalent * Aleutian Spacer System (KOS51454) * Globus Xpand-R ( K060665). * Medtronic Verte-stack (K030736) * OEC Rezaian (K84 1189) * DePuy Surgical Titanium Mesh (K003043) * Osteotech VBR (003 155) * Theken VuMesh (K070381) * Interpore Cros…
Orthopedic Equipment Co., Inc.1984—
*K003043Surgical Titanium Mesh System
Summary page 1
…an Spacer System (KOS51454) * Globus Xpand-R ( K060665). * Medtronic Verte-stack (K030736) * OEC Rezaian (K84 1189) * DePuy Surgical Titanium Mesh (K003043) * Osteotech VBR (003 155) * Theken VuMesh (K070381) * Interpore Cross Expandable PEEK VER (K040928) 4. Descript…
Depuyacromed2001—
*K003155Vertebral Body ReplacementOsteotech, Inc.2001—
*K070381Theken VU Mesh VBR System
Summary page 1
…* Medtronic Verte-stack (K030736) * OEC Rezaian (K84 1189) * DePuy Surgical Titanium Mesh (K003043) * Osteotech VBR (003 155) * Theken VuMesh (K070381) * Interpore Cross Expandable PEEK VER (K040928) 4. Description of the device: The Santorini Corpectomy Cage System…
Theken Spine, LLC2007—
*K040928Expandable Peek VBR Implant
Summary page 1
…Rezaian (K84 1189) * DePuy Surgical Titanium Mesh (K003043) * Osteotech VBR (003 155) * Theken VuMesh (K070381) * Interpore Cross Expandable PEEK VER (K040928) 4. Description of the device: The Santorini Corpectomy Cage System consists of a hollow tube structure manufactured fr…
Interpore Cross Intl.2004—

Also cleared against K060665: 4 other devices →

What descends from it? (18)

See all 18

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142016CAPRIK2m, Inc.201412
K170055CAPRI Corpectomy Cage SystemK2m201711
K171704CAPRI Corpectomy Cage SystemK2m201710
K151481Sahara Stabilization SystemK2m, Inc.20155
K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170

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 28 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
  • 3 of the 28 ancestors have a recall of any class.
  • Of its descendants, K142016 (K2m, Inc., 2014) has gone furthest, with 12 descendants of its own.
  • 4 other devices also cite its predicate K060665.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Santorini Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral bodies due to tumor or trauma (ie. fracture). The Santorini Spinal System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The Santorini device may be used with allograft or autograft.

For all the above indications the Santorini implants 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

Indications for use as stated in the FDA summary.

Also cleared against K060665

4 other devices cite the same predicate.

  • K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers…Globus Medical, Inc. · 2017
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™…Globus Medical, Inc. · 2017
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS…Globus Medical, Inc. · 2016
  • K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K111294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111294: Santorini Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111294

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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