510(k) · Cleared
ClearedCervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eisertech, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 30, 2012 as substantially equivalent to K110915 (Eisertech, LLC, 2011) and 1 other predicate after a 20-day review. Its family tree reaches back 13 generations to 2001. 22 later devices descend from it.
- Decided
- Aug 30, 2012
- Review
- 20 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K003155 (2001). 67 ancestors in all, the oldest K841189 (1984). 22 later devices descend from it, 2 citing it directly.
- 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 backK110915 Cervical CageEisertech, LLC · 2011
- This deviceK122444 Cervical CageEisertech, LLC · 2012
- Descendant · cites it directly · 12 of its ownK173347 STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique…Centinel Spine, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK181115 CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
- Descendant · 3 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
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 backK110915 Cervical CageEisertech, LLC · 2011
- This deviceK122444 Cervical CageEisertech, LLC · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc. · 2018 · cites it directly12descendants
- K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018 · cites it directly8descendants
- K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022 · 2 generations on4descendants
- K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020 · 2 generations on4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 3 generations on3descendants
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 | K110915 | Cervical Cage | Eisertech, LLC | 2011 | — |
| 0 (this device) | K122444 | Cervical Cage | Eisertech, LLC | 2012 | — |
| +1 | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX… | Centinel Spine, Inc. | 2018 | — |
| +1 | K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc. | 2018 | — |
| +2 | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | 2022 | — |
| +2 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
| +3 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K110915 | Cervical CageSummary page 2…ials The devices are manufactured from medical grade PEEK (ASTMV F2026) with tantalum radiographic markers .(ASTMV F560) Predicate Devices Eisertech, LLC Cervical Cage (k1 10915) Nexxt Spine Honour Spacer System (k1 20345) Technological Characteristics The Cervical Cage geometry is unchanged from that ap… | 2011 |
| * | K120345 | Honour Spacer SystemSummary page 2…cal grade PEEK (ASTMV F2026) with tantalum radiographic markers .(ASTMV F560) Predicate Devices Eisertech, LLC Cervical Cage (k1 10915) Nexxt Spine Honour Spacer System (k1 20345) Technological Characteristics The Cervical Cage geometry is unchanged from that approved in k1 10915. The main material of con… | 2012 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 6 of the 67 ancestors have a recall of any class.
- Of its descendants, K173347 (Centinel Spine, Inc., 2018) has gone furthest, with 12 descendants of its own.
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. 2012, 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 Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) 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 intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122444: Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122444
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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