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 Jun 2, 2010 as substantially equivalent to K083026 (Medtronic Sofamor Danek, 2008) and 1 other predicate after a 132-day review. Its family tree reaches back 10 generations to 1984. 1 of the 1,038 devices in its family, counting itself, has a Class I recall. 1,008 later devices descend from it.
- Decided
- Jun 2, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K841189 (1984). 29 ancestors in all. 1,008 later devices descend from it, 16 citing it directly. 1 of the 1,038 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 808 of its ownK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 2 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 3 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- Descendant · 2 generations on · 682 of its ownK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- Descendant · 3 generations on · 676 of its ownK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
Showing 5 of 1,008 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,008 · See all- K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly808descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on723descendants
- K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 3 generations on709descendants
- K121683Acculif TL CageCoalign Innovations, Inc. · 2012 · 2 generations on682descendants
- K123752Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · 3 generations on676descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| 0 (this device) | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +2 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +3 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +2 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| +3 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 14 | 0 |
| 2014 | 14 | 0 |
| 2015 | 20 | 0 |
| 2016 | 37 | 0 |
| 2017 | 66 | 0 |
| 2018 | 68 | 0 |
| 2019 | 86 | 0 |
| 2020 | 90 | 0 |
| 2021 | 91 | 1 |
| 2022 | 95 | 0 |
| 2023 | 122 | 0 |
| 2024 | 114 | 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? (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 |
|---|---|---|---|
| * | K083026 | Clydesdale Spinal SystemSummary page 2…ts, was provided which demonstrated that the subject CLYDESDALETM Spinal System is substantially equivalent to the predicate CLYDESDALETm device cleared in K083026, SE 12/29/08 and the CAPSTONE® device cleared in K073291, SE 04/24/08. VHLI Brief Discussion of the Non-Clinical Tes… | 2008 |
| * | K073291 | Capstone Spinal SystemSummary page 2…ESDALETM Spinal System is substantially equivalent to the predicate CLYDESDALETm device cleared in K083026, SE 12/29/08 and the CAPSTONE® device cleared in K073291, SE 04/24/08. VHLI Brief Discussion of the Non-Clinical Tests Submitted The following mechanical tests of the subje… | 2008 |
What descends from it? (1,008)
See all 1,00816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110543 | Crescent (R) Spinal System Titanium | 2011 | 808 |
| K113528 | Clydesdale (R) Spinal System | 2011 | 361 |
| K112405 | Clydesdales Spinal System | 2011 | 296 |
| K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail… | 2013 | 281 |
| K132897 | Clydesdale Spinal System | 2013 | 279 |
| K210425 | Catalyft PL Expandable Interbody System | 2021 | 56 |
| K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 37 |
| K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 36 |
| K110927 | Mectalif | 2011 | 30 |
| K123978 | Capstone L Spinal System | 2013 | 13 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K110543 (Medtronic Sofamor Danek USA, Inc., 2011) has gone furthest, with 808 descendants of its own.
- 7 other devices also cite its predicate K083026.
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. 2010, 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 (DOD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade I 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 (DOD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade I 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 he 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/K100175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100175: 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/K100175
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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