510(k) · Cleared
ClearedClydesdale Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 29, 2008 after an 80-day review. The FDA summary names no predicate by number. 1 of the 1,043 devices in its family, counting itself, has a Class I recall. 1,042 later devices descend from it.
- Decided
- Dec 29, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
1,042 later devices descend from it, 8 citing it directly. 1 of the 1,043 devices in this family, counting this one, has a Class I recall.
- This deviceK083026 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 808 of its ownK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 796 of its ownK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 3 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Showing 5 of 1,042 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 1,042 · See all- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly1,008descendants
- K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on808descendants
- K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009 · cites it directly796descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 3 generations on723descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083026 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +1 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +2 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| +2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +3 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 12 | 0 |
| 2013 | 17 | 0 |
| 2014 | 18 | 0 |
| 2015 | 22 | 0 |
| 2016 | 44 | 0 |
| 2017 | 70 | 0 |
| 2018 | 71 | 0 |
| 2019 | 89 | 0 |
| 2020 | 91 | 0 |
| 2021 | 91 | 1 |
| 2022 | 95 | 0 |
| 2023 | 122 | 0 |
| 2024 | 115 | 0 |
| 2025 | 96 | 0 |
| 2026 | 81 | 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.
1 device in this family has a Class I recall. 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1,042)
See all 1,0428 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100175 | Clydesdale Spinal System | 2010 | 1,008 |
| K090353 | Perimeter Interbody Fusion Device | 2009 | 796 |
| K112405 | Clydesdales Spinal System | 2011 | 296 |
| K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail… | 2013 | 281 |
| K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | 2013 | 246 |
| K122989 | Biomet Lateral Spacer System | 2012 | 171 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
| K211689 | KEYSTONE PEEK Cage System | 2021 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100175 (Medtronic Sofamor Danek, 2010) has gone furthest, with 1,008 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The CLYDESDALETM Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALETM Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved…
Read the full statement (117 words)
The CLYDESDALETM Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALETM Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083026: Clydesdale Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083026
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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