510(k) Report

510(k) · Cleared

Cleared

Zavation Ibf Systems

K112664510(k) TraditionalCleared Dec 23, 2011101-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

Zavation, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Dec 23, 2011 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 6 other predicates after a 101-day review. Its family tree reaches back 12 generations to 1984. 37 later devices descend from it.

Decided
Dec 23, 2011
Review
101 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
7

Its longest line of descent runs back 12 generations to K841189 (1984). 62 ancestors in all. 37 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 3 other ancestors2008: 6 other ancestors2007: 1 other ancestor1999: 1 other ancestor2005: 4 other ancestors2002: 7 other ancestors2001: 9 other ancestors2004: 9 other ancestors2003: 7 other ancestors1996: 1 other ancestor2000: 1 other ancestor2012: 2 descendants cleared2018: 2 descendants cleared2014: 3 descendants cleared2015: 2 descendants cleared2017: 1 descendant cleared2022: 3 descendants cleared2016: 1 descendant cleared2019: 3 descendants cleared2023: 4 descendants cleared2021: 5 descendants cleared2020: 2 descendants cleared2026: 2 descendants cleared2024: 2 descendants cleared2025: 5 descendants 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. · 2010K110843 · Aleutian Spacer System · K2m, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 7 other ancestors3 generations back: 14 other ancestors4 generations back: 11 other ancestors5 generations back: 8 other ancestors6 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant K110843 · Aleutian Spacer System · 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+5
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  4. 2 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  5. 1 generation backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
  6. This deviceK112664 Zavation Ibf SystemsZavation, LLC · 2011
  7. Descendant · cites it directly · 32 of its ownK120576 Zavation Ibf SystemZavation, LLC · 2012
  8. Descendant · 2 generations on · 24 of its ownK162206 Zavation IBFZavation, LLC · 2017
  9. Descendant · 3 generations on · 22 of its ownK181246 Zavation IBF SystemZavation Medical Products, LLC · 2018
  10. Descendant · 4 generations on · 13 of its ownK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
  11. Descendant · 4 generations on · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
Show all 12 generations
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 5 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 4 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 2 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  12. 1 generation backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
  13. This deviceK112664 Zavation Ibf SystemsZavation, LLC · 2011

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2012: 22014: 32015: 22016: 12017: 12018: 22019: 32020: 22021: 52022: 32023: 42024: 22025: 52026: 2
2012high 5 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 37 · See all
  • K120576Zavation Ibf SystemZavation, LLC · 2012 · cites it directly32descendants
  • K162206Zavation IBFZavation, LLC · 2017 · 2 generations on24descendants
  • K181246Zavation IBF SystemZavation Medical Products, LLC · 2018 · 3 generations on22descendants
  • K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019 · 4 generations on13descendants
  • K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−11K990148Stackable Cage SystemDepuy Motech Acromed1999—
−10K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−9K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−8K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−7K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−6K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−5K051454Aleutian Spacer SystemK2m, LLC2005—
−4K063399Aleutian Spacer SystemK2m, Inc.2007—
−3K082698Aleutian Ibf SystemK2m, Inc.2009—
−2K101302Aleutian Ibf SystemK2m, Inc.2010—
−1K110843Aleutian Spacer SystemK2m, Inc.2011—
0 (this device)K112664Zavation Ibf SystemsZavation, LLC2011—
+1K120576Zavation Ibf SystemZavation, LLC2012—
+2K162206Zavation IBFZavation, LLC2017—
+3K181246Zavation IBF SystemZavation Medical Products, LLC2018—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC2019—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200190
200270
200370
200490
200540
200710
200860
200930
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201430
201520
201610
201710
201820
201930
202020
202150
202230
202340
202420
202550
202620
FIG. 1 — Lineage of K112664, 1984–2026Source: 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? (7)

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
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 2
…es are manufactured from medical grade PEEK Zeniva ZA-500(ASTM F2026) with Tantalum alloy position markers (ASTMV F560). Predicate Device: Lumbar I/F Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusi…
Depuy Spine, Inc.1999—
*K110843Aleutian Spacer System
Summary page 2
…ade PEEK Zeniva ZA-500(ASTM F2026) with Tantalum alloy position markers (ASTMV F560). Predicate Device: Lumbar I/F Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K(073351) Synthes Spine,…
K2m, Inc.2011—
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 2
…y position markers (ASTMV F560). Predicate Device: Lumbar I/F Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K(073351) Synthes Spine, Oracle, OPAL Spacer (1(072791) Synthes Spine, T-PAL…
Ldr Spine USA2009—
*K073351Crystal
Summary page 2
…Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K(073351) Synthes Spine, Oracle, OPAL Spacer (1(072791) Synthes Spine, T-PAL Spacer (K(100089) Globus Medical, Patriot Spacers (K(072970)…
Spinal Elements, Inc.2008—
*K072791Oracle Spacer, Opal Spacer
Summary page 2
…em, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K(073351) Synthes Spine, Oracle, OPAL Spacer (1(072791) Synthes Spine, T-PAL Spacer (K(100089) Globus Medical, Patriot Spacers (K(072970) Technological Characteristics: The Zavation I…
Synthes Spine20071
*K100089Synthes T-Pal Spacer
Summary page 2
…terbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K(073351) Synthes Spine, Oracle, OPAL Spacer (1(072791) Synthes Spine, T-PAL Spacer (K(100089) Globus Medical, Patriot Spacers (K(072970) Technological Characteristics: The Zavation IBF System possesses the same technologi…
Synthes Spine20101
*K072970Patriot Spacers
Summary page 2
…ents, Crystal, Interbody Fusion Device (K(073351) Synthes Spine, Oracle, OPAL Spacer (1(072791) Synthes Spine, T-PAL Spacer (K(100089) Globus Medical, Patriot Spacers (K(072970) Technological Characteristics: The Zavation IBF System possesses the same technological characteristics as the predicates. Thes…
Globus Medical, Inc.2008—

Also cleared against P960025: 98 other devices →

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K120576Zavation Ibf SystemZavation, LLC201232
K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184
K122021Sterispine LC CageSafe Orthopaedics20122

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 27 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
  • 8 of the 62 ancestors have a recall of any class.
  • Of its descendants, K120576 (Zavation, LLC, 2012) has gone furthest, with 32 descendants of its own.
  • 98 other devices also cite its predicate P960025.

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. 2011, 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 acervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Ti, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The…

Read the full statement (226 words)

When used as acervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Ti, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device isintended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from 12 to S1, for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis. ODD isdefined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device isintended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

Indications for use as stated in the FDA summary.

Also cleared against P960025

98 other devices cite the same predicate.

  • K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC · 2024
  • K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018

More from Zavation, LLC

15 FDA decisions under this applicant name. See the company

  • K162206Zavation IBFZavation, LLC · 2017
  • K162575Z-LINKPC SystemZavation, LLC · 2017
  • K162824Z-Span Plate SystemZavation, LLC · 2017
  • K161016Z-Clamp ISP SystemZavation, LLC · 2016
  • K153404Zavation Spinal SystemZavation, LLC · 2016

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/K112664 · printed Nov 4, 2026

Cite this page

510(k) Report. “K112664: Zavation Ibf Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112664

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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