510(k) · Cleared
ClearedGemini-C Hybrid Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 3, 2017 as substantially equivalent to K150619 (Orthofix, Inc., 2015) and 8 other predicates after a 104-day review. Its family tree reaches back 16 generations to 2001. 1 of the 143 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 3, 2017
- Review
- 104 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 16 generations to K003155 (2001). 142 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 143 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
- This deviceK170844 Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 10 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 9 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 8 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 7 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 6 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 5 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
- This deviceK170844 Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −10 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −6 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −5 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −3 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −1 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015 | — |
| 0 (this device) | K170844 | Gemini-C Hybrid Cervical Interbody System | Osseus Fusion Systems, LLC | 2017 | — |
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 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 13 | 0 |
| 2004 | 22 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 18 | 1 |
| 2009 | 12 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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.
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? (9)
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 |
|---|---|---|---|
| * | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemSummary page 4…ection 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate x CONSTRUX Mini PEEK Ti Spacer System (K150619) Device x Crystal Cervical Cage (K073351) x Endoskeleton® TC (K100889)… | 2015 |
| * | K073351 | CrystalSummary page 4…Orthopedic Primary Predicate x CONSTRUX Mini PEEK Ti Spacer System (K150619) Device x Crystal Cervical Cage (K073351) x Endoskeleton® TC (K100889) x BAK/Cervical Interbody Fusion (P980048)… | 2008 |
| * | K100889 | Endoskeleton TCSummary page 4…x CONSTRUX Mini PEEK Ti Spacer System (K150619) Device x Crystal Cervical Cage (K073351) x Endoskeleton® TC (K100889) x BAK/Cervical Interbody Fusion (P980048) Additional Predicate x Fusion Advantage Interbody… | 2010 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 4…x Crystal Cervical Cage (K073351) x Endoskeleton® TC (K100889) x BAK/Cervical Interbody Fusion (P980048) Additional Predicate x Fusion Advantage Interbody Cages, (K083425) Devices x Brantigan I/F Cage (P9… | 2001 |
| * | K083425 | Fusion Advantage Cervical Cage, Fusion Advantage Lumbar CageSummary page 4…x Endoskeleton® TC (K100889) x BAK/Cervical Interbody Fusion (P980048) Additional Predicate x Fusion Advantage Interbody Cages, (K083425) Devices x Brantigan I/F Cage (P960025) x LDR Spine Cervical Interbody Fusion S… | 2009 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…x BAK/Cervical Interbody Fusion (P980048) Additional Predicate x Fusion Advantage Interbody Cages, (K083425) Devices x Brantigan I/F Cage (P960025) x LDR Spine Cervical Interbody Fusion System (K091088) x Nanovis Forti… | 1999 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 4…vantage Interbody Cages, (K083425) Devices x Brantigan I/F Cage (P960025) x LDR Spine Cervical Interbody Fusion System (K091088) x Nanovis FortiCore™(K140280) x 4-Webb Cervical STS Interbody Fusion D… | 2009 |
| * | K140280 | ForticoreSummary page 4…x Brantigan I/F Cage (P960025) x LDR Spine Cervical Interbody Fusion System (K091088) x Nanovis FortiCore™(K140280) x 4-Webb Cervical STS Interbody Fusion Device (K121741) The Osseus Fusi… | 2014 |
| * | K121741 | 4-Web Cervical STS (Spinal Truss System)Summary page 4…Interbody Fusion System (K091088) x Nanovis FortiCore™(K140280) x 4-Webb Cervical STS Interbody Fusion Device (K121741) The Osseus Fusion Systems’ Gemini-C Hybrid Cervical Interbody System is used to… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 13 of the 142 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K150619.
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. 2017, 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 Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with…
Read the full statement (116 words)
The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
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/K170844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170844: Gemini-C Hybrid Cervical Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170844
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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