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 Mar 22, 2018 as substantially equivalent to K133321 (Alliance Partners, LLC, 2014) and 4 other predicates after a 174-day review. Its family tree reaches back 14 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 22, 2018
- Review
- 174 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K003155 (2001). 103 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK161127 The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
- This deviceK173128 Alamo® CAlliance Partners, LLC · 2018
- Descendant · cites it directly · 0 of its ownK252737 DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025
- Descendant · cites it directly · 0 of its ownK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK161127 The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
- This deviceK173128 Alamo® CAlliance Partners, LLC · 2018
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 |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −8 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −3 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −1 | K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | Life Spine, Inc. | 2016 | — |
| 0 (this device) | K173128 | Alamo® C | Alliance Partners, LLC | 2018 | — |
| +1 | K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025 | — |
| +1 | K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 12 | 0 |
| 2005 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K133321 | Alamo CSummary page 4…egulatory Class: Class II Product Code: ODP Review Panel: Orthopedic 5.3 Predicate Device Primary Predicate: Alamo® C [K133321 & K112361] Additional Predicates: Life Spine Small PLATEAU® (PLATEAU‐C Ti) Spacer System [K161127]… | 2014 |
| * | K112361 | Alamo CSummary page 4…Class: Class II Product Code: ODP Review Panel: Orthopedic 5.3 Predicate Device Primary Predicate: Alamo® C [K133321 & K112361] Additional Predicates: Life Spine Small PLATEAU® (PLATEAU‐C Ti) Spacer System [K161127] Rhaus… | 2011 |
| * | K161127 | The Small PLATEAU (PLATEAU-C) Spacer SystemSummary page 4…ic 5.3 Predicate Device Primary Predicate: Alamo® C [K133321 & K112361] Additional Predicates: Life Spine Small PLATEAU® (PLATEAU‐C Ti) Spacer System [K161127] Rhausler Plage™ Anterior Cervical Fusion System [K111272] Alliance Par… | 2016 |
| * | K111272 | Rhausler Plage Anterior Cervical Fusion SystemSummary page 4…Additional Predicates: Life Spine Small PLATEAU® (PLATEAU‐C Ti) Spacer System [K161127] Rhausler Plage™ Anterior Cervical Fusion System [K111272] Alliance Partners Nakoma® ACP [K141993] 5.4 Reason for 510(k) Submission The purpose of th… | 2011 |
| * | K141993 | Nakoma AcpSummary page 4…pacer System [K161127] Rhausler Plage™ Anterior Cervical Fusion System [K111272] Alliance Partners Nakoma® ACP [K141993] 5.4 Reason for 510(k) Submission The purpose of this submission is to expand the Alamo C Interbody Fusion System… | 2014 |
What descends from it? (2)
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?
- The line of descent spans 17 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 8 of the 103 ancestors have a recall of any class.
- Of its descendants, K252737 (Degen Medical, 2025) has gone furthest, with 0 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. 2018, 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 Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
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/K173128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173128: 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/K173128
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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