510(k) · Cleared
ClearedAlamo C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Partners, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 30, 2011 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 30, 2011
- Review
- 105 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK112361 Alamo CAlliance Partners, LLC · 2011
- Descendant · cites it directly · 3 of its ownK133321 Alamo CAlliance Partners, LLC · 2014
- Descendant · cites it directly · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK252737 DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025
- Descendant · 2 generations on · 0 of its ownK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K133321Alamo CAlliance Partners, LLC · 2014 · cites it directly3descendants
- K173128Alamo® CAlliance Partners, LLC · 2018 · cites it directly2descendants
- K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025 · 2 generations on0descendants
- K213115CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112361 | Alamo C | Alliance Partners, LLC | 2011 | — |
| +1 | K133321 | Alamo C | Alliance Partners, LLC | 2014 | — |
| +1 | K173128 | Alamo® C | Alliance Partners, LLC | 2018 | — |
| +2 | K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025 | — |
| +2 | K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K133321 (Alliance Partners, LLC, 2014) has gone furthest, with 3 descendants of its own.
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. 2011, 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 | — |
https://510kreport.com/device/K112361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112361: Alamo C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112361
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026