510(k) Report

510(k) · Cleared

Cleared

Camber Spine Coveris Cervical Cage

K133529510(k) TraditionalCleared Mar 20, 2014125-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

Camber Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Mar 20, 2014 as substantially equivalent to K073440 (Corelink, LLC, 2008) and 2 other predicates after a 125-day review. Its family tree reaches back 11 generations to 2001. 10 later devices descend from it.

Decided
Mar 20, 2014
Review
125 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
3

Its longest line of descent runs back 11 generations to K003155 (2001). 57 ancestors in all, the oldest K841189 (1984). 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 6 other ancestors2009: 3 other ancestors2006: 1 other ancestor2005: 2 other ancestors2001: 7 other ancestors1999: 2 other ancestors2007: 3 other ancestors2004: 8 other ancestors2003: 6 other ancestors1996: 2 other ancestors1984: 1 other ancestor2002: 4 other ancestors2000: 1 other ancestor2017: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K061836 · Avs Asl Peek Spacer System · Stryker Spine · 2006K120345 · Honour Spacer System · Nexxt Spine, LLC · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 11 other ancestors4 generations back: 10 other ancestors5 generations back: 9 other ancestors6 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K120345 · Honour Spacer System · Nexxt Spine, LLC · 2012K061836 · Avs Asl Peek Spacer System · Stryker Spine · 2006K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · 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
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  4. 2 generations backK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
  5. 1 generation backK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
  6. This deviceK133529 Camber Spine Coveris Cervical CageCamber Spine · 2014
  7. Descendant · cites it directly · 6 of its ownK172446 SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017
  8. Descendant · 2 generations on · 2 of its ownK193153 SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
  9. Descendant · 2 generations on · 1 of its ownK222806 Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
  10. Descendant · cites it directly · 1 of its ownK170550 Coveris Cervical Cage SystemCamber Spine Technologies · 2017
  11. Descendant · 3 generations on · 0 of its ownK253894 BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o. · 2026
Show all 11 generations
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations backK012254 VBROsteotech, Inc. · 2001
  3. 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 2 generations backK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
  11. 1 generation backK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
  12. This deviceK133529 Camber Spine Coveris Cervical CageCamber Spine · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22018: 12020: 12022: 12023: 22025: 12026: 1
2016high 2 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 10 · See all
  • K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017 · cites it directly6descendants
  • K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020 · 2 generations on2descendants
  • K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022 · 2 generations on1descendant
  • K170550Coveris Cervical Cage SystemCamber Spine Technologies · 2017 · cites it directly1descendant
  • K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−10K012254VBROsteotech, Inc.2001—
−9K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−6K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−5K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−3K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−2K061836Avs Asl Peek Spacer SystemStryker Spine2006—
−1K120345Honour Spacer SystemNexxt Spine, LLC2012—
0 (this device)K133529Camber Spine Coveris Cervical CageCamber Spine2014—
+1K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies2017—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies2020—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC2022—
+1K170550Coveris Cervical Cage SystemCamber Spine Technologies2017—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199920
200010
200170
200240
200360
200480
200520
200610
200730
200860
200930

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
201810
202010
202210
202320
202510
202610
FIG. 1 — Lineage of K133529, 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.

Planning a device in ODP? 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? (3)

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
*K073440Foundation Cage
Summary page 1
…21 CFR 888.3080 Classification Panel: Orthopedic Product Code ODP Reason for 510k New Device Predicate Devices Corelink Foundation Cage (K 073440), Nexxt Honour Spacer (K120345) & Spinal Elements Crystal (K073351) Device Description The Camber Sp…
Corelink, LLC2008—
*K120345Honour Spacer System
Summary page 1
…Product Code ODP Reason for 510k New Device Predicate Devices Corelink Foundation Cage (K 073440), Nexxt Honour Spacer (K120345) & Spinal Elements Crystal (K073351) Device Description The Camber Spine Coveris Cage series of intervertebral body fusion…
Nexxt Spine, LLC2012—
*K073351Crystal
Summary page 1
…for 510k New Device Predicate Devices Corelink Foundation Cage (K 073440), Nexxt Honour Spacer (K120345) & Spinal Elements Crystal (K073351) Device Description The Camber Spine Coveris Cage series of intervertebral body fusion devices are u…
Spinal Elements, Inc.2008—

Also cleared against K073440: 4 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176
K170550Coveris Cervical Cage SystemCamber Spine Technologies20171
K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160

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 13 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 5 of the 57 ancestors have a recall of any class.
  • Of its descendants, K172446 (Camber Spine Technologies, 2017) has gone furthest, with 6 descendants of its own.
  • 4 other devices also cite its predicate K073440.

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. 2014, 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?

When used as a cervical intervertebral fusion device, the Coveris devices are indicated for use at one level in the cervical spine, from C0-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (ODD) with up to Grade 1 spondylolisthesis. ODD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation (such as anterior cervical plating systems, or posterior systems) systems cleared for use in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K073440

4 other devices cite the same predicate.

  • K162496Foundation 3D InterbodyCorelink, LLC · 2017
  • K150847Foundation Interbody DevicesCorelink, LLC · 2015
  • K130506Imse P-TlifInstitute of Musculoskeletal Science & Education · 2013
  • K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013

More from Camber Spine

4 FDA decisions under this applicant name. See the company

  • K143490VERTA Corpectomy CageCamber Spine · 2015
  • K133366Orthros Posterior Stabilization SystemCamber Spine · 2014
  • K134038Camber Spine Diagon Oblique CageCamber Spine · 2014

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/K133529 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133529: Camber Spine Coveris Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133529

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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