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, Ltd. · OJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Cleared on Jul 11, 2008 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) and 3 other predicates after a 375-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Jul 11, 2008
- Review
- 375 days
- Class
- Class II
- Product code
- OJB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010911 (2001). 7 ancestors in all, the oldest K002063 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 3 generations backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- 2 generations backK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
- 1 generation backK051821 Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005
- This deviceK071810 Inion Spinal Graft Containment SystemInion, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK151360 Inion Spinal Graft Containment SystemInion OY · 2015
Most influential descendants
Showing 1 of 1 · See all- K151360Inion Spinal Graft Containment SystemInion OY · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −3 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| −2 | K041105 | Macropore Hydrosorb Spine System | Macropore Biosurgery, Inc. | 2004 | — |
| −1 | K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion System | Inion, Ltd. | 2005 | — |
| 0 (this device) | K071810 | Inion Spinal Graft Containment System | Inion, Ltd. | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (4)
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 |
|---|---|---|---|
| * | K010911 | Macropore OS Spinal SystemSummary page 1…pedic Product Code: KWQ Common name: Appliance, fixation, spinal intervertebral body Regulation number: 21 CFR 888.3060 Predicate devices Macropore OS Spine™ System (K010911) MacroPore Hydrosorb™ Spine System (K041105) Inion S-1™ Biodegradable Anterior Cervical Fusion System (K051821) Biomet Tantalum… | 2001 |
| * | K041105 | Macropore Hydrosorb Spine SystemSummary page 1…nce, fixation, spinal intervertebral body Regulation number: 21 CFR 888.3060 Predicate devices Macropore OS Spine™ System (K010911) MacroPore Hydrosorb™ Spine System (K041105) Inion S-1™ Biodegradable Anterior Cervical Fusion System (K051821) Biomet Tantalum Beads — Radiographic Marker (K010348) Devic… | 2004 |
| * | K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion SystemSummary page 1…888.3060 Predicate devices Macropore OS Spine™ System (K010911) MacroPore Hydrosorb™ Spine System (K041105) Inion S-1™ Biodegradable Anterior Cervical Fusion System (K051821) Biomet Tantalum Beads — Radiographic Marker (K010348) Device description and principles of operation Inion Spinal Graft Contai… | 2005 |
| * | K010348 | Tantalum Beads - Radiographic MarkerSummary page 1…m (K010911) MacroPore Hydrosorb™ Spine System (K041105) Inion S-1™ Biodegradable Anterior Cervical Fusion System (K051821) Biomet Tantalum Beads — Radiographic Marker (K010348) Device description and principles of operation Inion Spinal Graft Containment System includes plates, meshes and screws which… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151360 | Inion Spinal Graft Containment System | 2015 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K151360 (Inion OY, 2015) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K010911.
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. 2008, 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?
Inion Spinal Graft Containment 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. The device is not intended for load bearing indications.
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/K071810 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071810: Inion Spinal Graft Containment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071810
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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