510(k) · Cleared
ClearedORIO-Ti Intervertebral Body Fusion Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinecraft, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 30, 2021 as substantially equivalent to K090887 (SpineCraft, 2009) and 6 other predicates after a 100-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Sep 30, 2021
- Review
- 100 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K003155 (2001). 347 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- 2 generations backK161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2016
- 1 generation backK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- This deviceK211935 ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 7 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 6 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 4 generations backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- 3 generations backK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- 2 generations backK161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2016
- 1 generation backK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- This deviceK211935 ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −7 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −6 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K112459 | Synthes Zero-P | Synthes Spine Co.Lp | 2011 | — |
| −4 | K131449 | Coalition Spacer | Globus Medical, Inc. | 2013 | — |
| −3 | K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 | — |
| −2 | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2016 | — |
| −1 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2017 | — |
| 0 (this device) | K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 11 | 0 |
| 1997 | 7 | 0 |
| 1998 | 15 | 0 |
| 1999 | 12 | 0 |
| 2000 | 19 | 0 |
| 2001 | 24 | 0 |
| 2002 | 16 | 0 |
| 2003 | 24 | 0 |
| 2004 | 35 | 0 |
| 2005 | 21 | 0 |
| 2006 | 17 | 0 |
| 2007 | 18 | 0 |
| 2008 | 30 | 0 |
| 2009 | 17 | 0 |
| 2010 | 14 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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? (7)
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 4…Class II 3. Predicate or legally marketed devices which are substantially equivalent: Primary ORIO Intervertebral Body Fusion Cages (K090887) SpineCraft, LLC Additional predicate devices BAK/C Vista Interbody Fusion (P980048) Zimmer Shoreline A… | 2009 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 4…ent: Primary ORIO Intervertebral Body Fusion Cages (K090887) SpineCraft, LLC Additional predicate devices BAK/C Vista Interbody Fusion (P980048) Zimmer Shoreline ACS Anterior Cervical Standalone (K170569) SeaSpine IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and… | 2001 |
| * | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSummary page 4…K090887) SpineCraft, LLC Additional predicate devices BAK/C Vista Interbody Fusion (P980048) Zimmer Shoreline ACS Anterior Cervical Standalone (K170569) SeaSpine IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) Huvexel Co., Ltd Brigade Hyperlordotic ALIF… | 2017 |
| * | K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Summary page 4…C Vista Interbody Fusion (P980048) Zimmer Shoreline ACS Anterior Cervical Standalone (K170569) SeaSpine IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) Huvexel Co., Ltd Brigade Hyperlordotic ALIF Lumbar Cage (K123045) Nuvasive APEX-DL Spine System (K143683) Spin… | 2017 |
| * | K123045 | Brigade Standalone SystemSummary page 4…ervical Standalone (K170569) SeaSpine IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) Huvexel Co., Ltd Brigade Hyperlordotic ALIF Lumbar Cage (K123045) Nuvasive APEX-DL Spine System (K143683) SpineCraft, LLC ASTRA Spine System (K150417) SpineCraft, LLC 4. Descri… | 2013 |
| * | K143683 | APEX-DL Spine SystemSummary page 4…A Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) Huvexel Co., Ltd Brigade Hyperlordotic ALIF Lumbar Cage (K123045) Nuvasive APEX-DL Spine System (K143683) SpineCraft, LLC ASTRA Spine System (K150417) SpineCraft, LLC 4. Description of the device: The subject devices a… | 2015 |
| * | K150417 | Astra Spine SystemSummary page 4…Huvexel Co., Ltd Brigade Hyperlordotic ALIF Lumbar Cage (K123045) Nuvasive APEX-DL Spine System (K143683) SpineCraft, LLC ASTRA Spine System (K150417) SpineCraft, LLC 4. Description of the device: The subject devices are intervertebral body fusion devices for use in cervi… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 companies; a new generation was cleared every 9 months on median.
- 31 of the 347 ancestors have a recall of any class.
- 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. 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 ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment prior to treatment with…
Read the full statement (294 words)
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine.
The ORIO-Ti lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.
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/K211935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211935: ORIO-Ti Intervertebral Body Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211935
Report an extraction error
Are you the manufacturer?
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