510(k) Report

510(k) · Cleared

Cleared

ACIF

K173148510(k) TraditionalCleared Dec 1, 201763-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

Coligne AG · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Dec 1, 2017 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 4 other predicates after a 63-day review. Its family tree reaches back 10 generations to 1984. 1 later device descends from it.

Decided
Dec 1, 2017
Review
63 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K841189 (1984). 40 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2002: 5 other ancestors2001: 9 other ancestors2005: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors1999: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2023: 1 descendant clearedReference device: K072326 · Ostapek VBR System · Co-Ligne AG · 2008K841189 · 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) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 6 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant K091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 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 · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  4. 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  5. 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  6. This deviceK173148 ACIFColigne AG · 2017
  7. Descendant · cites it directly · 0 of its ownK230478 Acro Composites Interbody SystemAcro Composites, LLC · 2023
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. This deviceK173148 ACIFColigne AG · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K230478Acro Composites Interbody SystemAcro Composites, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−4K043479MC+ Partial VBRLdr Spine USA2005—
−3K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−2K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
0 (this device)K173148ACIFColigne AG2017—
+1K230478Acro Composites Interbody SystemAcro Composites, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200190
200250
200340
200440
200520
200820
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K173148, 1984–2023Source: 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
*K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems
Summary page 4
…ODP CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate DePuy, BENGAL System (K081917) Device Spinal Elements, Crystal Cervical Cage (K073351) Secondary Predicate Zimmer, BAK/C Vista…
Depuy Spine, Inc.2009—
*K073351Crystal
Summary page 4
…Orthopedic Primary Predicate DePuy, BENGAL System (K081917) Device Spinal Elements, Crystal Cervical Cage (K073351) Secondary Predicate Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Devices LDR Spine Cervical Interbo…
Spinal Elements, Inc.2008—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 4
…ENGAL System (K081917) Device Spinal Elements, Crystal Cervical Cage (K073351) Secondary Predicate Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Devices LDR Spine Cervical Interbody Fusion System (K091088) Medtronic, Affinity…
Sulzer Spine-Tech2001—
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 4
…Cervical Cage (K073351) Secondary Predicate Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Devices LDR Spine Cervical Interbody Fusion System (K091088) Medtronic, Affinity Anterior Cervical Cage (P000028) Reference Device ostaP…
Ldr Spine USA2009—
*P000028Affinity (TM) Cage System
Summary page 4
…Fusion (P980048 S3) Devices LDR Spine Cervical Interbody Fusion System (K091088) Medtronic, Affinity Anterior Cervical Cage (P000028) Reference Device ostaPek® VBR System (K072326) The coLigne ACIF system ar…
Medtronic Sofamor Danek USA, Inc.2002—
†K072326Ostapek VBR SystemCo-Ligne AG2008—

Also cleared against K081917: 35 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K230478Acro Composites Interbody SystemAcro Composites, LLC20230

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 33 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
  • 3 of the 40 ancestors have a recall of any class.
  • Of its descendants, K230478 (Acro Composites, LLC, 2023) has gone furthest, with 0 descendants of its own.
  • 35 other devices also cite its predicate K081917.

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. 2017, 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 ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.

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 K081917

35 other devices cite the same predicate.

  • K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh…Medos International SARL · 2018
  • K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018
  • K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG · 2017
  • K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
  • K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway · 2015
  • K151352CONCORDE Bullet Spinal SystemMedos International SARL · 2015

More from Coligne AG

4 FDA decisions under this applicant name. See the company

  • K210306GII Spinal Fixation SystemColigne AG · 2021
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K173893TrabisColigne AG · 2018

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/K173148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173148: ACIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173148

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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