510(k) Report

510(k) · Cleared

Cleared

Vusion CS Plus

K122588510(k) TraditionalCleared Jun 12, 2013292-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

Ortho Development Corp. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jun 12, 2013 as substantially equivalent to K091088 (Ldr Spine USA, 2009) and 4 other predicates after a 292-day review. Its family tree reaches back 12 generations to 2001. 206 later devices descend from it.

Decided
Jun 12, 2013
Review
292 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
5

Its longest line of descent runs back 12 generations to K003155 (2001). 73 ancestors in all, the oldest K841189 (1984). 206 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2009: 3 other ancestors2008: 3 other ancestors2010: 1 other ancestor2007: 5 other ancestors2005: 7 other ancestors2002: 5 other ancestors2001: 8 other ancestors2004: 13 other ancestors2003: 7 other ancestors1999: 3 other ancestors1996: 2 other ancestors1984: 1 other ancestor2000: 1 other ancestor2018: 7 descendants cleared2017: 2 descendants cleared2019: 7 descendants cleared2020: 13 descendants cleared2021: 13 descendants cleared2025: 39 descendants cleared2026: 34 descendants cleared2024: 36 descendants cleared2023: 31 descendants cleared2022: 24 descendants 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 · 2005K060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK083311 · Aesculap Cespace Peek Intervertebral Body Fusion System · Aesculap Implant Systems, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 21 other ancestors4 generations back: 12 other ancestors5 generations back: 12 other ancestors6 generations back: 3 other ancestors7 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 20 descendants3 generations forward: 27 descendants4 generations forward: 36 descendants5 generations forward: 38 descendants6 generations forward: 39 descendants7 generations forward: 28 descendants8 generations forward: 11 descendants9 generations forward: 4 descendants10 generations forward: 1 descendant K083311 · Aesculap Cespace Peek Intervertebral Body Fusion System · Aesculap Implant Systems, Inc. · 2009K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 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+5+10
  1. Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 8 generations between
  3. 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  4. 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  5. 1 generation backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  6. This deviceK122588 Vusion CS PlusOrtho Development Corp. · 2013
  7. Descendant · cites it directly · 199 of its ownK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
  8. Descendant · 2 generations on · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
  9. Descendant · 3 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
  10. Descendant · 2 generations on · 131 of its ownK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
  11. Descendant · 3 generations on · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
Show all 12 generations
  1. Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations backK012254 VBROsteotech, Inc. · 2001
  3. 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. 1 generation backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  13. This deviceK122588 Vusion CS PlusOrtho Development Corp. · 2013

Showing 5 of 206 descendants. See all descendants

Descendants cleared per year

2017: 22018: 72019: 72020: 132021: 132022: 242023: 312024: 362025: 392026: 34
2017high 39 (2025) · low 2 (2017)2026

Most influential descendants

Showing 5 of 206 · See all
  • K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · cites it directly199descendants
  • K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 2 generations on159descendants
  • K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 3 generations on141descendants
  • K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019 · 2 generations on131descendants
  • K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · 3 generations on130descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−11K012254VBROsteotech, Inc.2001—
−10K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−7K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−6K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−5K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−4K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−3K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
−2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
−1K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009—
0 (this device)K122588Vusion CS PlusOrtho Development Corp.2013—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH20172
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH2017—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018—
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019—
+3K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT…Eit Emerging Implant Technologies GmbH2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199930
200010
200180
200250
200370
2004130
200570
200750
200830
200930
201010
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201870
201970
2020130
2021130
2022240
2023310
2024360
2025390
2026340
FIG. 1 — Lineage of K122588, 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? (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
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 1
…uly 11, 2012 .\/usion°h CS Plus Intervertebrai Body Fusiofi Device 21 CFR 888.3080, Intervertebral Body Fusion Device. ODP LDR Spine Cervical Interbody Fusion System (K091088) LDR Spine ROI-C Cervical Cage (K113559) LDR Spine Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Syst…
Ldr Spine USA2009—
*K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants
Summary page 1
…rtebrai Body Fusiofi Device 21 CFR 888.3080, Intervertebral Body Fusion Device. ODP LDR Spine Cervical Interbody Fusion System (K091088) LDR Spine ROI-C Cervical Cage (K113559) LDR Spine Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems Aleutian IBF System (K113138) KZM, I…
Ldr Spine USA, Inc.2011—
*K083311Aesculap Cespace Peek Intervertebral Body Fusion System
Summary page 1
…Fusion Device. ODP LDR Spine Cervical Interbody Fusion System (K091088) LDR Spine ROI-C Cervical Cage (K113559) LDR Spine Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems Aleutian IBF System (K113138) KZM, Inc. Crystal™ Intervertebral Body Fusion Device (K073351) Spinal…
Aesculap Implant Systems, Inc.2009—
*K113138Aleutian System
Summary page 1
…ystem (K091088) LDR Spine ROI-C Cervical Cage (K113559) LDR Spine Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems Aleutian IBF System (K113138) KZM, Inc. Crystal™ Intervertebral Body Fusion Device (K073351) Spinal Elements The Vusion® CS Plus system is designed for cerv…
K2m, Inc.2012—
*K073351Crystal
Summary page 1
…ne Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems Aleutian IBF System (K113138) KZM, Inc. Crystal™ Intervertebral Body Fusion Device (K073351) Spinal Elements The Vusion® CS Plus system is designed for cervical intervertebral body fusion. The implant is a non-sterile PE…
Spinal Elements, Inc.2008—

Also cleared against K091088: 50 other devices →

What descends from it? (206)

See all 206

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

NumberDeviceApplicantDecidedDescendants
K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017199
K172480icotec Interbody Cage SystemIcotec AG20185

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 12 years and passes through 6 companies; a new generation was cleared every 10 months on median.
  • 8 of the 73 ancestors have a recall of any class.
  • Of its descendants, K170503 (Eit Emerging Implant Technologies GmbH, 2017) has gone furthest, with 199 descendants of its own.
  • 50 other devices also cite its predicate K091088.

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. 2013, 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 Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine.

This device is intended to be used in patients who have had six weeks of non-operative treatment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K091088

50 other devices cite the same predicate.

  • K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc. · 2024
  • K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC · 2023
  • K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC · 2023
  • K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023
  • K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC · 2020
  • K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC · 2020

More from Ortho Development Corp.

45 FDA decisions under this applicant name. See the company

  • K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp. · 2025
  • K251052Trivicta® Hip StemOrtho Development Corp. · 2025
  • K242984BKS Revision SystemOrtho Development Corp. · 2024
  • K242833Legend® Acetabular ShellOrtho Development Corp. · 2024
  • K233758Trivicta™ Hip StemOrtho Development Corp. · 2024

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/K122588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122588: Vusion CS Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122588

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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