510(k) Report

510(k) · Cleared

Cleared

Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System

K182885510(k) TraditionalCleared Feb 6, 2019114-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

Medtronic Sofamor Danek USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 6, 2019 as substantially equivalent to K152623 (Medtronic Sofamor Danek USA, Inc., 2015) and 14 other predicates after a 114-day review. Its family tree reaches back 16 generations to 2001. 8 later devices descend from it.

Decided
Feb 6, 2019
Review
114 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
15

Its longest line of descent runs back 16 generations to K003155 (2001). 117 ancestors in all, the oldest K792352 (1979). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 2 other ancestors2014: 1 other ancestor2013: 2 other ancestors2008: 12 other ancestors2007: 8 other ancestors2006: 4 other ancestors2004: 16 other ancestors2003: 11 other ancestors2002: 8 other ancestors2000: 2 other ancestors1999: 3 other ancestors1997: 2 other ancestors2012: 1 other ancestor2011: 2 other ancestors2010: 2 other ancestors2009: 5 other ancestors2001: 9 other ancestors1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2005: 4 other ancestors1996: 2 other ancestors1995: 1 other ancestor1984: 1 other ancestor2020: 1 descendant cleared2019: 1 descendant cleared2024: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2025: 2 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 · 2010K100967 · Perimeter C Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011K132584 · Perimeter C Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K140417 · Divergence Mini-Plate Anterior Cervical Fusion System · Medtronic Sofamor Danek, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 10 other ancestors3 generations back: 14 other ancestors4 generations back: 21 other ancestors5 generations back: 14 other ancestors6 generations back: 14 other ancestors7 generations back: 7 other ancestors8 generations back: 4 other ancestors9 generations back: 2 other ancestors10 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K140417 · Divergence Mini-Plate Anterior Cervical Fusion System · Medtronic Sofamor Danek, Inc. · 2014K132584 · Perimeter C Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K100967 · Perimeter C Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011K100214 · 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. · 2001−15−10−50
  1. Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations between
  3. 3 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  4. 2 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  5. 1 generation backK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
  6. This deviceK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
  7. Descendant · cites it directly · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
  8. Descendant · cites it directly · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
  9. Descendant · 2 generations on · 1 of its ownK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · Recalled
  10. Descendant · 3 generations on · 0 of its ownK253577 IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025
  11. Descendant · 2 generations on · 0 of its ownK251431 FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025
Show all 16 generations
  1. Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 15 generations backK012254 VBROsteotech, Inc. · 2001
  3. 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 7 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 6 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 5 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 4 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  14. 3 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  15. 2 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 1 generation backK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
  17. This deviceK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019: 12020: 12021: 12023: 12024: 22025: 2
2019high 2 (2024) · low 0 (2022)2026

Most influential descendants

Showing 5 of 8 · See all
  • K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · cites it directly4descendants
  • K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · cites it directly2descendants
  • K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · 2 generations on1descendant
  • K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025 · 3 generations on0descendants
  • K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−15K012254VBROsteotech, Inc.2001—
−14K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−13K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−12K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−11K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−7K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−6K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−5K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010—
−3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—
−2K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−1K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.2014—
0 (this device)K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion…Medtronic Sofamor Danek USA, Inc.2019—
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion…Medtronic Sofamor Danek USA, Inc.2020—
+1K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC2019—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)20242
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199510
199620
199720
199810
199930
200020
200190
200280
2003110
2004160
200540
200640
200780
2008120
200950
201020
201120
201210
201320
201410
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
202110
202310
202420
202520
FIG. 1 — Lineage of K182885, 2001–2025Source: 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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (15)

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
*K152623ATLANTIS Anterior Cervical Plate System
Summary page 6
… 21 CFR 888.3080 Intervertebral body fusion device OVE, Device Product Code ODP  Primary Predicate 1- K152623 Atlantis™ Anterior Cervical Plate System (S.E 11/12/2015)  Predicate…
Medtronic Sofamor Danek USA, Inc.2015—
*K130640Atlantis Anterior Cervical Plate System
Summary page 6
… Primary Predicate 1- K152623 Atlantis™ Anterior Cervical Plate System (S.E 11/12/2015)  Predicate 2- K130640 Atlantis™ Anterior Cervical Plate System (S.E 06/04/2013) Predicate Devices  Predicate…
Medtronic Sofamor Danek USA, Inc.2013—
*K081038Atlantis Anterior Cervical Plate System
Summary page 6
… Predicate 2- K130640 Atlantis™ Anterior Cervical Plate System (S.E 06/04/2013) Predicate Devices  Predicate 3- K081038 Atlantis™ Anterior Cervical Plate System (S.E 08/15/2008)  Predicate…
Medtronic Sofamor Danek20083
*K063100Atlantis Anterior Cervical Plate System, Translational Plate
Summary page 6
…ces  Predicate 3- K081038 Atlantis™ Anterior Cervical Plate System (S.E 08/15/2008)  Predicate 4- K063100 Atlantis™ Anterior Cervical Plate System (S.E 02/23/2007)  Predicate…
Medtronic Sofamor Danek, Inc.20073
*K021461Atlantis Vision Anterior Cervical Plate System
Summary page 6
… Predicate 4- K063100 Atlantis™ Anterior Cervical Plate System (S.E 02/23/2007)  Predicate 5- K021461 Atlantis™ Anterior Cervical Plate System (S.E 07/22/2002)…
Medtronic Sofamor Danek20023
*K970806Acpii Anterior Cervical Plate System
Summary page 7
…K182885 Page 2 of 6  Predicate 6- K970806 Atlantis™ Anterior Cervical Plate System (S.E 05/02/197)  Predicat…
Sofamor Danek USA,Inc.1997—
*K140417Divergence Mini-Plate Anterior Cervical Fusion System
Summary page 7
… Predicate 6- K970806 Atlantis™ Anterior Cervical Plate System (S.E 05/02/197)  Predicate 7- K140417 Divergence™ Anterior Cervical Fusion System (S.E. 07/09/2014)  Pre…
Medtronic Sofamor Danek, Inc.2014—
*K141599Divergence Anterior Cervical Fusion System
Summary page 7
… Predicate 7- K140417 Divergence™ Anterior Cervical Fusion System (S.E. 07/09/2014)  Predicate 8- K141599 Divergence™ Anterior Cervical Fusion System (S.E. 01/21/2015)  Pre…
Medtronic Sofamor Danek USA, Inc.2015—
*K021761Premier Anterior Cervical Plate System
Summary page 7
… Predicate 8- K141599 Divergence™ Anterior Cervical Fusion System (S.E. 01/21/2015)  Predicate 9- K021761 Premier™ Anterior Cervical Plate System (S.E 09/17/2002)  Predicat…
Medtronic Sofamor Danek2002—
*K992110Premier Anterior Cervical Plate System
Summary page 7
… Predicate 9- K021761 Premier™ Anterior Cervical Plate System (S.E 09/17/2002)  Predicate 10- K992110 Premier™ Anterior Cervical Plate System (S.E 09/14/1999)  Predicat…
Sofamor Danek USA1999—
*K061274Venture Anterior Cervical Plate System
Summary page 7
… Predicate 10- K992110 Premier™ Anterior Cervical Plate System (S.E 09/14/1999)  Predicate 11- K061274 Venture™ Anterior Cervical Plate System (S.E 05/25/2006)  Predicat…
Medtronic Sofamor Danek2006—
*K042922Venture Anterior Cervical Plating System
Summary page 7
… Predicate 11- K061274 Venture™ Anterior Cervical Plate System (S.E 05/25/2006)  Predicate 12- K042922 Venture™ Anterior Cervical Plate System (S.E 11/19/2004)  Predicat…
Medtronic Sofamor Danek, Inc.2004—
*K030327Zephir Anterior Cervical System
Summary page 7
… Predicate 12- K042922 Venture™ Anterior Cervical Plate System (S.E 11/19/2004)  Predicate 13- K030327 Zephir™ Anterior Cervical Plate System (S.E. 02/26/2003)  Predicat…
Medtronic Sofamor Danek2003—
*K994239Zephir Anterior Cervical Plate System
Summary page 7
… Predicate 13- K030327 Zephir™ Anterior Cervical Plate System (S.E. 02/26/2003)  Predicate 14- K994239 Zephir™ Anterior Cervical Plate System (S.E. 06/19/2000)  Predicat…
Medtronic Sofamor Danek, Inc.2000—
*K141632Zevo (TM) Anterior Cervical Plate System
Summary page 7
… Predicate 14- K994239 Zephir™ Anterior Cervical Plate System (S.E. 06/19/2000)  Predicate 15- K141632 Zevo™ Anterior Cervical Plate System (S.E. 12/04/2014) The pre…
Medtronic Sofamor Danek USA, Inc.20141

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204
K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192

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 18 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 11 of the 117 ancestors have a recall of any class.
  • Of its descendants, K192502 (Medtronic Sofamor Danek USA, Inc., 2020) has gone furthest, with 4 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

Atlantis™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck…

Read the full statement (1,062 words)

Atlantis™ Anterior Cervical Plate System:

Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota bene: this device system is intended for anterior cervical intervertebral body fusions only.

Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Divergence™ Anterior Cervical Fusion System:

The Divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. Plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2) trauma (including fractures); 3) tumors; 4) deformity (defined as kyphosis, lordosis, or scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions.

The Divergence™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. 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 cage is to be used in patients who have had six weeks of non operative treatment. The Divergence™ cage must be used with supplemental fixation. The Divergence™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the Divergence™ components can be used only to treat cervical disc disease.

Divergence™ Anterior Cervical Fusion System (Stand-Alone Interbody)

The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. 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. The Divergence™ stand-alone cervical interbody device must be used with internal screw fixation. The Divergence™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Premier™ Anterior Cervical Plate System:

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota bene: this device system is intended for anterior cervical intervertebral body fusions only.

Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Venture™ Anterior Cervical Plate System:

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota bene: this device system is intended for anterior cervical intervertebral body fusions only.

Zephir™ Anterior Cervical Plate System:

Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota bene: this device system is intended for anterior cervical intervertebral body fusions only.

Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Zevo™ Anterior Cervical Plate System:

The Zevo™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota bene: this device system is intended for anterior cervical intervertebral body fusions only.

Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Indications for use as stated in the FDA summary.

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
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  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
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https://510kreport.com/device/K182885 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182885: Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182885

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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