510(k) · Cleared
ClearedC7 Anterior Cervical Intervertebral Fusion Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey Co, Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 10, 2012 as substantially equivalent to K090887 (SpineCraft, 2009) and 2 other predicates after a 100-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 10, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K010530 (2001). 42 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 7 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 6 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 5 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 4 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 3 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 2 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- 1 generation backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- This deviceK121320 C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK122801 Providence Cervical CageProvidence Medical Technology, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK161642 CAVUX™ Cervical CageProvidence Medical Technology, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −7 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −6 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −5 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −4 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −3 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −2 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| −1 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| 0 (this device) | K121320 | C7 Anterior Cervical Intervertebral Fusion Cage | Medyssey Co, Ltd. | 2012 | — |
| +1 | K122801 | Providence Cervical Cage | Providence Medical Technology, Inc. | 2013 | — |
| +2 | K161642 | CAVUX™ Cervical Cage | Providence Medical Technology, Inc. | 2016 | — |
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 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K090887 | Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion…Summary page 2…n, Medyssey believes that the subject Medyssey C7 Anterior Cervical Cage System is substantially equivalent to the SpineCraft, LLC ORIO Intervertebral Body Fusion Cages (K090887), Custom Spine, Inc. Pathway ACIF (K092904) and Biomet Spine C-Thru Anterior Spinal System (1(092336)… | 2009 |
| * | K092904 | Pathway Ivb/VBRSummary page 1…888.3080, Class 11 Predicate Device: -SpineCraft, LLC ORIO Intervertebral Body Fusion Cages (K&90887) * Custom Spine, Inc. Pathway ACIF (K092904) * Biomet Spine C-Thru Anterior Spinal System (K092336) Product Description: The Medyssey C7 Anterior C… | 2009 |
| * | K092336 | C-Thru Spinal SystemSummary page 1…ral Body Fusion Cages (K&90887) * Custom Spine, Inc. Pathway ACIF (K092904) * Biomet Spine C-Thru Anterior Spinal System (K092336) Product Description: The Medyssey C7 Anterior Cervical Interbody Fusion Cage system consists of a series… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122801 | Providence Cervical Cage | 2013 | 1 |
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 7 companies; a new generation was cleared every 6 months on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K122801 (Providence Medical Technology, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K090887.
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 C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the…
Read the full statement (111 words)
The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121320: C7 Anterior Cervical Intervertebral Fusion Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121320
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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