510(k) Report

510(k) · Cleared

Cleared

Anatomic Peek Cervical Fusion System

K112444510(k) TraditionalCleared Nov 15, 201183-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 Danck USA, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Nov 15, 2011 as substantially equivalent to K070173 (Medtronic Sofamor Danek, Inc., 2007) and 4 other predicates after an 83-day review. Its family tree reaches back 13 generations to 2001. 1 of the 413 devices in its family, counting itself, has a Class I recall. 324 later devices descend from it.

Decided
Nov 15, 2011
Review
83 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
5

Its longest line of descent runs back 13 generations to K003155 (2001). 88 ancestors in all, the oldest K792352 (1979). 324 later devices descend from it, 5 citing it directly. 1 of the 413 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2009: 5 other ancestors2008: 10 other ancestors2005: 4 other ancestors2004: 14 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 ancestor2013: 2 descendants cleared2020: 20 descendants cleared2014: 5 descendants cleared2018: 8 descendants cleared2015: 3 descendants cleared2017: 13 descendants cleared2016: 5 descendants cleared2019: 22 descendants cleared2024: 53 descendants cleared2023: 32 descendants cleared2025: 53 descendants cleared2022: 29 descendants cleared2021: 31 descendants cleared, 1 with a Class I recall12026: 48 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: 16 other ancestors3 generations back: 15 other ancestors4 generations back: 12 other ancestors5 generations back: 14 other ancestors6 generations back: 10 other ancestors7 generations back: 4 other ancestors8 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 15 descendants3 generations forward: 31 descendants4 generations forward: 39 descendants5 generations forward: 83 descendants, 1 with a Class I recall16 generations forward: 77 descendants7 generations forward: 39 descendants8 generations forward: 27 descendants9 generations forward: 7 descendants10 generations forward: 1 descendant 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+10
  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 deviceK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 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 deviceK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011

Showing 5 of 324 descendants. See all descendants

Descendants cleared per year

2013: 22014: 52015: 32016: 52017: 132018: 82019: 222020: 202021: 312022: 292023: 322024: 532025: 532026: 48
2013high 53 (2024) · low 2 (2013)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 324 · 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)K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011—
+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
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201450
201530
201650
2017130
201880
2019220
2020200
2021311
2022290
2023320
2024530
2025530
2026480
FIG. 1 — Lineage of K112444, 2001–2026Source: 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.

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K070173Verte-Stack Spinal System
Summary page 2
…subject ANATOMIC PEEKTM CERVICAL FUSION SYSTEM are substantially equivalent to predicates: * VERTE-STACK Anatomic PEEKTM Spinal System(K070 173, SE 3/14/2007) " CORNERSTONE® PSR Cervical Interbody Fusion Device…
Medtronic Sofamor Danek, Inc.2007—
*K100214Cornerstone PSR Cervical Interbody Fusion Device
Summary page 2
…omic PEEKTM Spinal System(K070 173, SE 3/14/2007) " CORNERSTONE® PSR Cervical Interbody Fusion Device (K 100214, SE 6/25/20 10) * PEEK PREVAILTM Cervical Interbody Device (K094042, SE 6/30/2010)…
Medtronic Sofamor Danek2010—
*K094042Peek Prevail Cervical Interbody Device
Summary page 2
…" CORNERSTONE® PSR Cervical Interbody Fusion Device (K 100214, SE 6/25/20 10) * PEEK PREVAILTM Cervical Interbody Device (K094042, SE 6/30/2010) " Depuy Bengal System (K081917, SE 5/22/2009) * S…
Medtronic Sofamor Danek2010—
*K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems
Summary page 2
…SE 6/25/20 10) * PEEK PREVAILTM Cervical Interbody Device (K094042, SE 6/30/2010) " Depuy Bengal System (K081917, SE 5/22/2009) * Small PLATEAU® (Plateau-C) (K093093, SE 10/13/20 10 IX. Discussion of Non-Clinical Test…
Depuy Spine, Inc.2009—
*K093093Small Plateau Spacer System
Summary page 2
…vice (K094042, SE 6/30/2010) " Depuy Bengal System (K081917, SE 5/22/2009) * Small PLATEAU® (Plateau-C) (K093093, SE 10/13/20 10 IX. Discussion of Non-Clinical Testing: The subject ANATOMIC PEEKTM CERVICAL FUSION Devices were teste…
Life Spine2010—

Also cleared against K070173: 4 other devices →

What descends from it? (324)

See all 324

5 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
K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119
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
K172568CervagePrecifit Medical, Ltd.20181

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 88 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.
  • 4 other devices also cite its predicate K070173.

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 ANATOMIC PEEK CERVICAL FUSION SYSTEM 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…

Read the full statement (117 words)

The ANATOMIC PEEK CERVICAL FUSION SYSTEM 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 ANATOMIC® PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K070173

4 other devices cite the same predicate.

  • K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
  • K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated · 2015
  • K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
  • K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008

More from Medtronic Sofamor Danck USA, Inc.

4 FDA decisions under this applicant name. See the company

  • K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
  • K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
  • K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011

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/K112444 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112444: Anatomic Peek 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/K112444

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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