510(k) · Decided
DecidedInion Spinal Graft Containment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion OY · OJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Cleared on Oct 6, 2015 as substantially equivalent to K071810 (Inion, Ltd., 2008) after a 139-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Oct 6, 2015
- Review
- 139 days
- Class
- Class II
- Product code
- OJB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010911 (2001). 8 ancestors in all, the oldest K002063 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 4 generations backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- 3 generations backK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
- 2 generations backK051821 Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005
- 1 generation backK071810 Inion Spinal Graft Containment SystemInion, Ltd. · 2008
- This deviceK151360 Inion Spinal Graft Containment SystemInion OY · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −4 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| −3 | K041105 | Macropore Hydrosorb Spine System | Macropore Biosurgery, Inc. | 2004 | — |
| −2 | K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion System | Inion, Ltd. | 2005 | — |
| −1 | K071810 | Inion Spinal Graft Containment System | Inion, Ltd. | 2008 | — |
| 0 (this device) | K151360 | Inion Spinal Graft Containment System | Inion OY | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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.
Planning a device in OJB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K071810 | Inion Spinal Graft Containment SystemSummary page 5…Spinal intervertebral body fixation orthosis Regulation number 888.3060 Predicate device Inion Spinal Graft Containment System (K071810) Conformance with performance Compliance to voluntary consensus standards is listed in the standards… | 2008 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All OJB devicesOJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OJB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OJB
Too few OJB 510(k)s in any year since 2007 to give a median.
Recalls per year · OJB
No recall names OJB since 2007.
Adverse event reports per year · OJB
1in 2015
MAUDE reports naming product code OJB, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Inion spinal graft containment plate system, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151360: Inion Spinal Graft Containment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151360
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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