510(k) Report

510(k) · Cleared

Cleared

C-Box Peek Cervical Ibf

K132991510(k) TraditionalCleared Feb 12, 2014141-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 Feb 12, 2014 as substantially equivalent to K082801 (Us Spine, 2008) and 3 other predicates after a 141-day review. Its family tree reaches back 13 generations to 1984. 9 later devices descend from it.

Decided
Feb 12, 2014
Review
141 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
4

Its longest line of descent runs back 13 generations to K841189 (1984). 76 ancestors in all. 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 3 other ancestors2008: 10 other ancestors2009: 5 other ancestors2003: 9 other ancestors1999: 1 other ancestor1996: 1 other ancestor2007: 2 other ancestors2005: 5 other ancestors2002: 7 other ancestors2001: 9 other ancestors2004: 9 other ancestors2000: 1 other ancestor2018: 1 descendant cleared2023: 3 descendants cleared2022: 2 descendants cleared2026: 2 descendants cleared2025: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K051454 · Aleutian Spacer System · K2m, LLC · 2005K063399 · Aleutian Spacer System · K2m, Inc. · 2007K082698 · Aleutian Ibf System · K2m, Inc. · 2009K101302 · Aleutian Ibf System · K2m, Inc. · 2010K103169 · Aleuttian · K2m, Inc. · 2011K130699 · Aleutian Spinal System · K2m, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 15 other ancestors4 generations back: 16 other ancestors5 generations back: 9 other ancestors6 generations back: 7 other ancestors7 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K130699 · Aleutian Spinal System · K2m, Inc. · 2013K103169 · Aleuttian · K2m, Inc. · 2011K101302 · Aleutian Ibf System · K2m, Inc. · 2010K082698 · Aleutian Ibf System · K2m, Inc. · 2009K063399 · Aleutian Spacer System · K2m, Inc. · 2007K051454 · Aleutian Spacer System · K2m, LLC · 2005K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50
  1. Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations between
  3. 3 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  4. 2 generations backK103169 AleuttianK2m, Inc. · 2011
  5. 1 generation backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
  6. This deviceK132991 C-Box Peek Cervical IbfInnovasis, Inc. · 2014
  7. Descendant · cites it directly · 8 of its ownK181115 CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018
  8. Descendant · 2 generations on · 4 of its ownK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
  9. Descendant · 3 generations on · 2 of its ownK231899 HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
  10. Descendant · 2 generations on · 1 of its ownK222041 CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. · 2023
  11. Descendant · 4 generations on · 0 of its ownK262025 Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis · 2026
Show all 13 generations
  1. Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 6 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 5 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 4 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 3 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  12. 2 generations backK103169 AleuttianK2m, Inc. · 2011
  13. 1 generation backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
  14. This deviceK132991 C-Box Peek Cervical IbfInnovasis, Inc. · 2014

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2018: 12022: 22023: 32025: 12026: 2
2018high 3 (2023) · low 0 (2019)2026

Most influential descendants

Showing 5 of 9 · See all
  • K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018 · cites it directly8descendants
  • K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022 · 2 generations on4descendants
  • K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023 · 3 generations on2descendants
  • K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. · 2023 · 2 generations on1descendant
  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−12K990148Stackable Cage SystemDepuy Motech Acromed1999—
−11K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−10K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−9K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−8K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−7K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−6K051454Aleutian Spacer SystemK2m, LLC2005—
−5K063399Aleutian Spacer SystemK2m, Inc.2007—
−4K082698Aleutian Ibf SystemK2m, Inc.2009—
−3K101302Aleutian Ibf SystemK2m, Inc.2010—
−2K103169AleuttianK2m, Inc.2011—
−1K130699Aleutian Spinal SystemK2m, Inc.2013—
0 (this device)K132991C-Box Peek Cervical IbfInnovasis, Inc.2014—
+1K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.2018—
+2K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.2022—
+3K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.2023—
+2K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.2023—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200190
200270
200390
200490
200550
200720
2008100
200950
201130
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202220
202330
202510
202620
FIG. 1 — Lineage of K132991, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K082801Phantom Plus Cage System
Summary page 2
…K1 32991 page 2 of 4 Substantially Equivalent Devices: K082801 PhantomTM Plus Cage System (US Spine) K1 30699 Aleutian Spinal System (K2M)…
Us Spine2008—
*K130699Aleutian Spinal System
Summary page 2
…page 2 of 4 Substantially Equivalent Devices: K082801 PhantomTM Plus Cage System (US Spine) K1 30699 Aleutian Spinal System (K2M) K1 20486 AVS AS PEEK Spacer (Stryker)…
K2m, Inc.2013—
*K120486Avs as Peek Spacer
Summary page 2
…tantially Equivalent Devices: K082801 PhantomTM Plus Cage System (US Spine) K1 30699 Aleutian Spinal System (K2M) K1 20486 AVS AS PEEK Spacer (Stryker) K103660 Breckenridge Cervical IBF (Lanx) Device Descriptio…
Stryker Spine2012—
*K103660Lanx Cervical Intervertebral Body Fusion System
Summary page 2
…(US Spine) K1 30699 Aleutian Spinal System (K2M) K1 20486 AVS AS PEEK Spacer (Stryker) K103660 Breckenridge Cervical IBF (Lanx) Device Description: C-Boxe PEEK Cervical IBF The single use devices…
Lanx, Inc.2011—

Also cleared against K082801: 12 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188

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 30 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
  • 6 of the 76 ancestors have a recall of any class.
  • Of its descendants, K181115 (Innovasis, Inc., 2018) has gone furthest, with 8 descendants of its own.
  • 12 other devices also cite its predicate K082801.

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?

The Innovasis C-Box PEEK Cervical IBF device 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 C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryto Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K082801

12 other devices cite the same predicate.

  • K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
  • K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd. · 2017
  • K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd. · 2016
  • K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
  • K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 20141 recall
  • K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012

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/K132991 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132991: C-Box Peek Cervical Ibf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132991

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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