510(k) · Cleared
Clearedicotec Interbody Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec AG · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 17, 2018 as substantially equivalent to K122588 (Ortho Development Corp., 2013) and 7 other predicates after a 274-day review. Its family tree reaches back 13 generations to 2001. 1 of the 117 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- May 17, 2018
- Review
- 274 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 13 generations to K003155 (2001). 111 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 4 citing it directly. 1 of the 117 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK122588 Vusion CS PlusOrtho Development Corp. · 2013
- This deviceK172480 icotec Interbody Cage SystemIcotec AG · 2018
- Descendant · cites it directly · 2 of its ownK193378 CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK203683 CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK192897 icotec Cervical CageIcotec AG · 2020
- Descendant · cites it directly · 0 of its ownK232792 icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF…Icotec AG · 2024
- Descendant · 2 generations on · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK122588 Vusion CS PlusOrtho Development Corp. · 2013
- This deviceK172480 icotec Interbody Cage SystemIcotec AG · 2018
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020 · cites it directly2descendants
- K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021 · cites it directly1descendant
- K192897icotec Cervical CageIcotec AG · 2020 · cites it directly1descendant
- K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG · 2024 · cites it directly0descendants
- K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −1 | K122588 | Vusion CS Plus | Ortho Development Corp. | 2013 | — |
| 0 (this device) | K172480 | icotec Interbody Cage System | Icotec AG | 2018 | — |
| +1 | K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +1 | K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics, Ltd. | 2021 | — |
| +1 | K192897 | icotec Cervical Cage | Icotec AG | 2020 | — |
| +1 | K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage… | Icotec AG | 2024 | — |
| +2 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 1 |
| 2009 | 9 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122588 | Vusion CS PlusSummary page 5…C 20005 Phone: 202.552.5800 [email protected] August 4, 2017 21 CFR §888.3080 Intervertebral body fusion device 11 ODP, MAX Cervical: Ortho Development Vusion CS+ (K122588) Lumbar: Scient’X Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PL… | 2013 |
| * | K080588 | Scient'x Tribeca VBRSummary page 5…cra.com August 4, 2017 21 CFR §888.3080 Intervertebral body fusion device 11 ODP, MAX Cervical: Ortho Development Vusion CS+ (K122588) Lumbar: Scient’X Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign… | 2008 |
| * | K100305 | Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Summary page 5…80 Intervertebral body fusion device 11 ODP, MAX Cervical: Ortho Development Vusion CS+ (K122588) Lumbar: Scient’X Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign AccuLIF (K093669, K112095), Zimmer TM-S… | 2011 |
| * | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSummary page 5…fusion device 11 ODP, MAX Cervical: Ortho Development Vusion CS+ (K122588) Lumbar: Scient’X Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign AccuLIF (K093669, K112095), Zimmer TM-S Fusion Device (K11111… | 2012 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 5…t Vusion CS+ (K122588) Lumbar: Scient’X Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign AccuLIF (K093669, K112095), Zimmer TM-S Fusion Device (K111119) K172480 PAGE2OF 3 Indications for U… | 2009 |
| * | K093669 | Sec Ibf CageSummary page 5…Scient’X Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign AccuLIF (K093669, K112095), Zimmer TM-S Fusion Device (K111119) K172480 PAGE2OF 3 Indications for Use: Cervical The icotec Cerv… | 2010 |
| * | K112095 | Acculif TL-Peek Ibf CageSummary page 5…Tribeca Cage (K080588) icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign AccuLIF (K093669, K112095), Zimmer TM-S Fusion Device (K111119) K172480 PAGE2OF 3 Indications for Use: Cervical The icotec Cervical Cage… | 2011 |
| * | K111119 | Trabecular Metal (TM) Fusion DeviceSummary page 5…Spinal Implant (K100305), Kimba Cage (K111792), Precision Spine Shurfit PLIF Interbody Cage (K092193) and CoAlign AccuLIF (K093669, K112095), Zimmer TM-S Fusion Device (K111119) K172480 PAGE2OF 3 Indications for Use: Cervical The icotec Cervical Cage is intended for spinal fusion proced… | 2011 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 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.
- 11 of the 111 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K193378 (CarboFix Orthopedics, Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K122588.
How does its category compare?
All ODP devicesODP 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
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-Tl) 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 packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical…
Read the full statement (312 words)
The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-Tl) 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 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.
The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autogratft.
The icotec ETurn™ TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autogratft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172480: icotec Interbody Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172480
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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