510(k) · Cleared
ClearedORIO-3D Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SpineCraft · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 16, 2026 as substantially equivalent to K212701 (Eminent Spine, 2023) and 8 other predicates after a 199-day review. Its family tree reaches back 27 generations to 1984. 1 of the 479 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 16, 2026
- Review
- 199 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 27 generations to K841189 (1984). 478 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 479 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK203201 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2021
- 2 generations backK210271 NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2021
- 1 generation backK230894 NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
- This deviceK253260 ORIO-3D Cage SystemSpineCraft · 2026
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 7 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 4 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 3 generations backK203201 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2021
- 2 generations backK210271 NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2021
- 1 generation backK230894 NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
- This deviceK253260 ORIO-3D Cage SystemSpineCraft · 2026
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −4 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −3 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2021 | — |
| −2 | K210271 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2021 | — |
| −1 | K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2023 | — |
| 0 (this device) | K253260 | ORIO-3D Cage System | SpineCraft | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 12 | 0 |
| 2003 | 19 | 0 |
| 2004 | 29 | 0 |
| 2005 | 20 | 0 |
| 2006 | 14 | 0 |
| 2007 | 21 | 0 |
| 2008 | 50 | 1 |
| 2009 | 37 | 0 |
| 2010 | 27 | 0 |
| 2011 | 36 | 0 |
| 2012 | 23 | 0 |
| 2013 | 26 | 0 |
| 2014 | 29 | 0 |
| 2015 | 21 | 0 |
| 2016 | 16 | 0 |
| 2017 | 12 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
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 |
|---|---|---|---|
| * | K212701 | Eminent Spine 3D Cervical Interbody Fusion SystemSummary page 6…uct Code Predicate Trade Name / Predicate # Predicate Devices (Primary Predicate is listed first): ODP Eminent Spine 3D Cervical Interbody Fusion System / K212701 ODP BAK/C Vista Interbody Fusion / P980048 S3 ODP… | 2023 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 6…s listed first): ODP Eminent Spine 3D Cervical Interbody Fusion System / K212701 ODP BAK/C Vista Interbody Fusion / P980048 S3 ODP HEDRON Cervical Spacers / K191243 ODP CO… | 2001 |
| * | K191243 | HEDRON Cervical SpacersSummary page 6…m / K212701 ODP BAK/C Vista Interbody Fusion / P980048 S3 ODP HEDRON Cervical Spacers / K191243 ODP CONSTRUX Mini Ti Spacer System / K203342 MAX… | 2019 |
| * | K203342 | CONSTRUX Mini Ti Spacer SystemSummary page 6…/ P980048 S3 ODP HEDRON Cervical Spacers / K191243 ODP CONSTRUX Mini Ti Spacer System / K203342 MAX Eminent Spine 3D Lumbar Interbody Fusion Systems (Straight and… | 2021 |
| * | K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsSummary page 6…MAX Eminent Spine 3D Lumbar Interbody Fusion Systems (Straight and Curved TLIF, PLIF) / K230219 MAX HEDRON™ Lumbar Spacer / K191391 MAX Lucent… | 2023 |
| * | K191391 | HEDRON Lumbar SpacersSummary page 6…sion Systems (Straight and Curved TLIF, PLIF) / K230219 MAX HEDRON™ Lumbar Spacer / K191391 MAX Lucent - Lumbar Intervertebral Body Fusion Device / K071724… | 2019 |
| * | K071724 | LucentSummary page 6…MAX HEDRON™ Lumbar Spacer / K191391 MAX Lucent - Lumbar Intervertebral Body Fusion Device / K071724 OVD Eminent Spine Standalone ALIF Interbody Fusion System / K221936… | 2007 |
| * | K221936 | Standalone ALIF Interbody Fusion SystemSummary page 6…Lucent - Lumbar Intervertebral Body Fusion Device / K071724 OVD Eminent Spine Standalone ALIF Interbody Fusion System / K221936 OVD Modulus ALIF System / K230894 The ORIO-3D Cage Syste… | 2022 |
| * | K230894 | NuVasive Modulus ALIF SystemSummary page 6…OVD Eminent Spine Standalone ALIF Interbody Fusion System / K221936 OVD Modulus ALIF System / K230894 The ORIO-3D Cage System devices are additively manufactured implants from titanium Device Descrip… | 2023 |
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 51 of the 478 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K212701.
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. 2026, 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 ORIO-3D Intervertebral Body Fusion Cervical Cages are indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine in skeletally mature patients with cervical degenerative disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-Tl. DDD is defined as neck pain of discogenic origin with…
Read the full statement (522 words)
The ORIO-3D Intervertebral Body Fusion Cervical Cages are indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine in skeletally mature patients with cervical degenerative disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-Tl. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and imaging studies. The ORIO-3D Cervical Cages are designed for use with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone and with an FDA cleared cervical supplemental fixation system. The hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ORIO-3D Cervical Cages in the cervical spine.
The ORIO-3D Intervertebral Body Fusion Transforaminal Lumbar (TLIF or P-TLIF) Cages are indicated for intervertebral Body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-Sl). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and imaging studies. Additionally, the ORIO-3D Intervertebral Body Fusion Transforaminal Lumbar Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis and sagittal deformity. The ORIO-3D Transforaminal Lumbar Cages are designed for use with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or cortico-cancellous bone. The ORIO-3D Transforaminal Lumbar Cages are intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbosacral spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the ORIO-3D Transforaminal Lumbar Cages.
The ORIO-3D Intervertebral Body Fusion Anterior Lumbar (ALIF) Cages are indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Additionally, the ORIO-3D Intervertebral Body Fusion Anterior Lumbar Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis and sagittal deformity. When used with three titanium alloy ANTERIS bone screws, the ORIO-3D ALIF 10 ° - 20 ° lordotic cages may be used as a standalone cage system in patients with DDD. Hyperlordotic ORIO-3D ALIF cages (>20 ° lordosis) must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbosacral spine. The ORIO-3D ALIF Cages are designed for use with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or cortico-cancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
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/K253260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253260: ORIO-3D Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253260
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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