510(k) · Cleared
ClearedInion S-1 Biodegradable Anterior Cervical Fusion 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 Nov 25, 2005 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) and 1 other predicate after a 143-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 25, 2005
- Review
- 143 days
- Class
- Class II
- Product code
- OJB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010911 (2001). 5 ancestors in all, the oldest K002063 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 2 generations backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- 1 generation backK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
- This deviceK051821 Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK071810 Inion Spinal Graft Containment SystemInion, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK151360 Inion Spinal Graft Containment SystemInion OY · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −2 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| −1 | K041105 | Macropore Hydrosorb Spine System | Macropore Biosurgery, Inc. | 2004 | — |
| 0 (this device) | K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion System | Inion, Ltd. | 2005 | — |
| +1 | K071810 | Inion Spinal Graft Containment System | Inion, Ltd. | 2008 | — |
| +2 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (2)
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…Regulation number: 21 CFR 888.3040 Regulation name: Smooth or threaded metallic bone fixation fastener Product Code: HWC PREDICATE DEVICES MacroPore OS Spinal System K010911 MacroPore Hydrosorb Spine System K041105 CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards e… | 2001 |
| * | K041105 | Macropore Hydrosorb Spine SystemSummary page 1…lation name: Smooth or threaded metallic bone fixation fastener Product Code: HWC PREDICATE DEVICES MacroPore OS Spinal System K010911 MacroPore Hydrosorb Spine System K041105 CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards exist for this device. Compliance to volun… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071810 | Inion Spinal Graft Containment System | 2008 | 1 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K071810 (Inion, Ltd., 2008) has gone furthest, with 1 descendant 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.
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 S-1TM BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications. The INION S_1TM BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are not intended for…
Read the full statement (113 words)
The INION S-1TM BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.
The INION S_1TM BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are not intended for use in and are contraindicated for:
• Load bearing indications unless used in conjunction with traditional rigid fixation.
• Active or potential infection.
• Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051821: Inion S-1 Biodegradable Anterior Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051821
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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