510(k) · Cleared
ClearedFIX-C 3D Ti ACIF 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 Feb 18, 2025 as substantially equivalent to K233839 (Gbs Commonwealth Co., Ltd., 2023) and 2 other predicates after a 60-day review. Its family tree reaches back 26 generations to 1984. 1 of the 466 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 18, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 26 generations to K841189 (1984). 465 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 466 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- 2 generations backK232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- 1 generation backK233839 Peridot-PT Anterior Cervical Intervertebral body fusion System…Gbs Commonwealth Co., Ltd. · 2023
- This deviceK243915 FIX-C 3D Ti ACIF SystemJeil Medical Corporation · 2025
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 16 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 15 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 14 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 13 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 12 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 11 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 10 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 9 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- 8 generations backK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- 7 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- 6 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 5 generations backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- 4 generations backK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- 3 generations backK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- 2 generations backK232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- 1 generation backK233839 Peridot-PT Anterior Cervical Intervertebral body fusion System…Gbs Commonwealth Co., Ltd. · 2023
- This deviceK243915 FIX-C 3D Ti ACIF SystemJeil Medical Corporation · 2025
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −16 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −15 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −14 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −13 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −12 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −11 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −10 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −9 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| −8 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| −7 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| −6 | K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019 | 1 |
| −5 | K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020 | — |
| −4 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2021 | — |
| −3 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| −2 | K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| −1 | K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| 0 (this device) | K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 39 | 0 |
| 2005 | 28 | 0 |
| 2006 | 16 | 0 |
| 2007 | 19 | 0 |
| 2008 | 46 | 1 |
| 2009 | 36 | 0 |
| 2010 | 31 | 0 |
| 2011 | 37 | 0 |
| 2012 | 23 | 0 |
| 2013 | 24 | 0 |
| 2014 | 22 | 0 |
| 2015 | 19 | 0 |
| 2016 | 13 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code IK233839 Peridot-PT Anterior Cervical Intervertebral body fusion System IODP I K241738… | 2023 |
| * | K241738 | PYXIS 3D Titanium Cervical Cage systemSummary page 5…Product Code IK233839 Peridot-PT Anterior Cervical Intervertebral body fusion System IODP I K241738 PYXIS 3D Titanium Cervical Cage System IODP I K212266… | 2024 |
| * | K212266 | FIX-C PEEK Anterior Cervical Interbody SystemSummary page 5…n System IODP I K241738 PYXIS 3D Titanium Cervical Cage System IODP I K212266 FIX-C PEEK Anterior Cervical Interbody System IODP Device Desc… | 2021 |
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 17 companies; a new generation was cleared every 1.0 years on median.
- 48 of the 465 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use…
Read the full statement (113 words)
The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1.
The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243915: FIX-C 3D Ti ACIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243915
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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