510(k) Report

510(k) · Cleared

Cleared

Cornerstone (R) PSR Cervical Fusion System

K111264510(k) SpecialCleared Oct 12, 2011161-day reviewClass II21 CFR 888.3080

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

Medtronic Sofamor Danek USA · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Oct 12, 2011 as substantially equivalent to K100214 (Medtronic Sofamor Danek, 2010) and 3 other predicates after a 161-day review. Its family tree reaches back 13 generations to 2001. 1 of the 419 devices in its family, counting itself, has a Class I recall. 331 later devices descend from it.

Decided
Oct 12, 2011
Review
161 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
4

Its longest line of descent runs back 13 generations to K003155 (2001). 87 ancestors in all, the oldest K792352 (1979). 331 later devices descend from it, 6 citing it directly. 1 of the 419 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 5 other ancestors2004: 14 other ancestors2008: 10 other ancestors2005: 4 other ancestors2003: 9 other ancestors2002: 6 other ancestors2001: 8 other ancestors1999: 2 other ancestors1996: 2 other ancestors2007: 5 other ancestors2006: 3 other ancestors2000: 1 other ancestor1984: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2015: 4 descendants cleared2013: 1 descendant cleared2026: 51 descendants cleared2020: 20 descendants cleared2016: 5 descendants cleared2014: 5 descendants cleared2017: 13 descendants cleared2019: 22 descendants cleared2022: 30 descendants cleared2018: 7 descendants cleared2024: 54 descendants cleared2021: 31 descendants cleared, 1 with a Class I recall12023: 33 descendants cleared2025: 55 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×3: 3 generations cleared close together, K040536 (2004), K041556 (2004), K043561 (2004) ×3: 3 generations cleared close together, K060719 (2006), K062133 (2006), K070173 (2007) K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K100214 · Cornerstone PSR Cervical Interbody Fusion Device · Medtronic Sofamor Danek · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 15 other ancestors3 generations back: 14 other ancestors4 generations back: 14 other ancestors5 generations back: 11 other ancestors6 generations back: 12 other ancestors7 generations back: 4 other ancestors8 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 19 descendants3 generations forward: 41 descendants4 generations forward: 50 descendants5 generations forward: 83 descendants, 1 with a Class I recall16 generations forward: 66 descendants7 generations forward: 34 descendants8 generations forward: 26 descendants9 generations forward: 6 descendants K100214 · Cornerstone PSR Cervical Interbody Fusion Device · Medtronic Sofamor Danek · 2010K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K070173 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2007K062133 · Modification to Verte-Stack Spinal System · Medtronic Spinal and Biologics Div · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50+5
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations between
  3. 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  4. 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  5. 1 generation backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  6. This deviceK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
  7. Descendant · cites it directly · 281 of its ownK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  8. Descendant · 2 generations on · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
  9. Descendant · 3 generations on · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
  10. Descendant · 4 generations on · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
  11. Descendant · 2 generations on · 130 of its ownK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
Show all 13 generations
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations backK012254 VBROsteotech, Inc. · 2001
  3. 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 4 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 1 generation backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  14. This deviceK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011

Showing 5 of 331 descendants. See all descendants

Descendants cleared per year

2013: 12014: 52015: 42016: 52017: 132018: 72019: 222020: 202021: 312022: 302023: 332024: 542025: 552026: 51
2013high 55 (2025) · low 1 (2013)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 331 · See all
  • K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc. · 2013 · cites it directly281descendants
  • K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on228descendants
  • K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on190descendants
  • K161379ELSA SpacersGlobus Medical, Inc. · 2016 · 4 generations on155descendants
  • K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on130descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−12K012254VBROsteotech, Inc.2001—
−11K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−8K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−4K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−3K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−2K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−1K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010—
0 (this device)K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011—
+1K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System…Medtronic Sofamor Danek, Inc.2013—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015—
+4K161379ELSA SpacersGlobus Medical, Inc.2016—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199620
199810
199920
200010
200180
200260
200390
2004140
200540
200630
200750
2008100
200950
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201450
201540
201650
2017130
201870
2019220
2020200
2021311
2022300
2023330
2024540
2025550
2026510
FIG. 1 — Lineage of K111264, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K100214Cornerstone PSR Cervical Interbody Fusion Device
Summary page 2
…strated that the subject device is substantially equivalent to the following currently marketed devices: CORNERSTONE® PSR Cervical Interbody Fusion Device (K1002 14, SE 6/25/2010); VERTE-STACK® Spinal System (K(041197, SE 8/9/2004); PLATEAU® (PLATEAU-C) Spacer System (K093093, Life S…
Medtronic Sofamor Danek2010—
*K041197Modification to Verte-Stack Spinal System
Summary page 2
…lent to the following currently marketed devices: CORNERSTONE® PSR Cervical Interbody Fusion Device (K1002 14, SE 6/25/2010); VERTE-STACK® Spinal System (K(041197, SE 8/9/2004); PLATEAU® (PLATEAU-C) Spacer System (K093093, Life Spine, SE 10/13/2010); and BENGAL® System (K081917, DePuy,…
Medtronic Sofamor Danek2004—
*K093093Small Plateau Spacer System
Summary page 2
…ERSTONE® PSR Cervical Interbody Fusion Device (K1002 14, SE 6/25/2010); VERTE-STACK® Spinal System (K(041197, SE 8/9/2004); PLATEAU® (PLATEAU-C) Spacer System (K093093, Life Spine, SE 10/13/2010); and BENGAL® System (K081917, DePuy, SE 5/22/2009). VII. Conclusion It was determined tha…
Life Spine2010—
*K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems
Summary page 2
…SE 6/25/2010); VERTE-STACK® Spinal System (K(041197, SE 8/9/2004); PLATEAU® (PLATEAU-C) Spacer System (K093093, Life Spine, SE 10/13/2010); and BENGAL® System (K081917, DePuy, SE 5/22/2009). VII. Conclusion It was determined that the subject device is substantially equivalent in design, ma…
Depuy Spine, Inc.2009—

Also cleared against K100214: 10 other devices →

What descends from it? (331)

See all 331

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

NumberDeviceApplicantDecidedDescendants
K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281
K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110
K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516
K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411
K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204
K242303MOD-COrthomod, LLC20260

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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 6 of the 87 ancestors have a recall of any class.
  • Of its descendants, K122037 (Medtronic Sofamor Danek, Inc., 2013) has gone furthest, with 281 descendants of its own.
  • 10 other devices also cite its predicate K100214.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The CORNERSTONE® PSR Cervical device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

Indications for use as stated in the FDA summary.

Also cleared against K100214

10 other devices cite the same predicate.

  • K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System…Medtronic Sofamor Danek USA, Inc. · 2020
  • K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017
  • K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
  • K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  • K130853Idys (TM) CClariance · 2013
  • K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody…Medtronic Sofamor Danek, Inc. · 2013

More from Medtronic Sofamor Danek USA

9 FDA decisions under this applicant name. See the company

  • K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
  • K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
  • K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
  • K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  • K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K111264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111264: Cornerstone (R) PSR Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111264

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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