510(k) Report

510(k) · Cleared

Cleared

CxHA PEEK Cervical IBF System

K181115510(k) TraditionalCleared Jul 16, 201880-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

Innovasis, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jul 16, 2018 as substantially equivalent to K172674 (Sapphire Medical Group, 2017) and 2 other predicates after an 80-day review. Its family tree reaches back 14 generations to 2001. 8 later devices descend from it.

Decided
Jul 16, 2018
Review
80 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
3

Its longest line of descent runs back 14 generations to K003155 (2001). 116 ancestors in all, the oldest K841189 (1984). 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2014: 1 other ancestor2013: 1 other ancestor2012: 2 other ancestors2011: 4 other ancestors2008: 16 other ancestors2010: 1 other ancestor2009: 9 other ancestors2006: 2 other ancestors2005: 10 other ancestors2003: 12 other ancestors1999: 2 other ancestors1996: 2 other ancestors2007: 8 other ancestors2004: 15 other ancestors2002: 6 other ancestors2001: 8 other ancestors1984: 1 other ancestor2000: 1 other ancestor2023: 3 descendants cleared2022: 2 descendants cleared2026: 2 descendants cleared2025: 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 · 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. · 2009K110915 · Cervical Cage · Eisertech, LLC · 2011K122444 · Cervical Cage · Eisertech, LLC · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 25 other ancestors4 generations back: 27 other ancestors5 generations back: 30 other ancestors6 generations back: 11 other ancestors7 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K122444 · Cervical Cage · Eisertech, LLC · 2012K110915 · Cervical Cage · Eisertech, LLC · 2011K083311 · 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
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations between
  3. 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  4. 2 generations backK110915 Cervical CageEisertech, LLC · 2011
  5. 1 generation backK122444 Cervical CageEisertech, LLC · 2012
  6. This deviceK181115 CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018
  7. Descendant · cites it directly · 4 of its ownK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
  8. Descendant · 2 generations on · 2 of its ownK231899 HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
  9. Descendant · cites it directly · 1 of its ownK222041 CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. · 2023
  10. Descendant · 3 generations on · 0 of its ownK262025 Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis · 2026
  11. Descendant · cites it directly · 0 of its ownK242303 MOD-COrthomod, LLC · 2026
Show all 14 generations
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 13 generations backK012254 VBROsteotech, Inc. · 2001
  3. 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  13. 2 generations backK110915 Cervical CageEisertech, LLC · 2011
  14. 1 generation backK122444 Cervical CageEisertech, LLC · 2012
  15. This deviceK181115 CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2022: 22023: 32025: 12026: 2
2022high 3 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 8 · See all
  • K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022 · cites it directly4descendants
  • K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023 · 2 generations on2descendants
  • K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. · 2023 · cites it directly1descendant
  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis · 2026 · 3 generations on0descendants
  • K242303MOD-COrthomod, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−13K012254VBROsteotech, Inc.2001—
−12K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−9K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−8K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−7K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−6K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−5K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
−4K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
−3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009—
−2K110915Cervical CageEisertech, LLC2011—
−1K122444Cervical CageEisertech, LLC2012—
0 (this device)K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.2018—
+1K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.2022—
+2K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.2023—
+1K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.2023—
+3K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis2026—
+1K242303MOD-COrthomod, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199920
200010
200180
200260
2003120
2004150
2005100
200620
200780
2008160
200990
201010
201140
201220
201310
201410
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
202330
202510
202620
FIG. 1 — Lineage of K181115, 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
*K172674Sapphire Cervical Implant System
Summary page 4
…Product Code: ODP Review Panel: Orthopedic - ASDB Applicable Standards: Primary Predicate: K172674 Sapphire Cervical Implant System (Sapphire Medical) Additional Predicates: K122444 Eisertech Cer…
Sapphire Medical Group2017—
*K122444Cervical Cage
Summary page 4
…Applicable Standards: Primary Predicate: K172674 Sapphire Cervical Implant System (Sapphire Medical) Additional Predicates: K122444 Eisertech Cervical Cage (Eisertech, LLC) K132991 C-Box PEEK Cervical IBF (Innovasis, Inc.) Devic…
Eisertech, LLC2012—
*K132991C-Box Peek Cervical Ibf
Summary page 4
…ical Implant System (Sapphire Medical) Additional Predicates: K122444 Eisertech Cervical Cage (Eisertech, LLC) K132991 C-Box PEEK Cervical IBF (Innovasis, Inc.) Device Description: CxHA PEEK Cervical IBF System The…
Innovasis, Inc.2014—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224
K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231
K242303MOD-COrthomod, LLC20260
K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250
K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220

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 17 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 10 of the 116 ancestors have a recall of any class.
  • Of its descendants, K220875 (Innovasis, Inc., 2022) has gone furthest, with 4 descendants of its own.

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. 2018, 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 Innovasis CxHA PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The CxHA device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.

Indications for use as stated in the FDA summary.

More from Innovasis, Inc.

33 FDA decisions under this applicant name. See the company

  • K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation…Innovasis, Inc. · 20251 recall
  • K250182Innovasis Navigation InstrumentsInnovasis, Inc. · 20251 recall
  • K241276Vector™ Pedicle Screw SystemInnovasis, Inc. · 20241 recall
  • K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
  • K223511Excella Navigation InstrumentsInnovasis, Inc. · 2023

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/K181115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181115: CxHA PEEK Cervical IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181115

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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