510(k) · Cleared
ClearedFIX-C PEEK Anterior Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 21, 2021 as substantially equivalent to K120275 (Synthes (Usa), LLC, 2012) after a 154-day review. Its family tree reaches back 14 generations to 2001. 7 later devices descend from it.
- Decided
- Dec 21, 2021
- Review
- 154 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K003155 (2001). 69 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK212266 FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation · 2021
- Descendant · cites it directly · 4 of its ownK240893 ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024
- Descendant · cites it directly · 1 of its ownK252781 MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti. · 2025
- Descendant · 2 generations on · 1 of its ownK252686 EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK260850 Osteomni Spinal Cages SystemOsteomni, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260340 HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical…HC Biologics, LLC · 2026
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK212266 FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024 · cites it directly4descendants
- K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti. · 2025 · cites it directly1descendant
- K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025 · 2 generations on1descendant
- K260850Osteomni Spinal Cages SystemOsteomni, Inc. · 2026 · 3 generations on0descendants
- K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K120275 | Synthes Acis/Vertebral Spacer CR | Synthes (Usa), LLC | 2012 | — |
| 0 (this device) | K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | 2021 | — |
| +1 | K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024 | — |
| +1 | K252781 | MSFX Mikron Peek Cages | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025 | — |
| +2 | K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025 | — |
| +3 | K260850 | Osteomni Spinal Cages System | Osteomni, Inc. | 2026 | — |
| +2 | K260340 | HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek… | HC Biologics, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K120275 | Synthes Acis/Vertebral Spacer CRSummary page 5…ication of Predicate Device(s) [21 CFR 807.92(a)(3)] The legally marketed device(s) to which substantial equivalence is claimed is/are: Predicate Device K120275 – SYNTHES ACIS/VERTEBRAL SPACER CR, SYNTHES (USA) LLC Reference Device K181806 – ARIX… | 2012 |
| † | K181806 | ARIX Sternal System | 2018 |
What descends from it? (7)
4 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 20 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 6 of the 69 ancestors have a recall of any class.
- Of its descendants, K240893 (Artfx Medical, 2024) has gone furthest, with 4 descendants of its own.
- 11 other devices also cite its predicate K120275.
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. 2021, 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 FIX-C PEEK Anterior Cervical Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the FIX-C PEEK Anterior Cervical Interbody System should be packed with autogenous bone graft and implanted via an anterior approach. The FIX-C PEEK Anterior Cervical Interbody System is intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212266 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212266: FIX-C PEEK Anterior Cervical Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212266
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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