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, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 18, 2012 as substantially equivalent to K113528 (Medtronic Sofamor Danek USA, Inc., 2011) after a 25-day review. Its family tree reaches back 12 generations to 1984. 14 later devices descend from it.
- Decided
- Sep 18, 2012
- Review
- 25 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K841189 (1984). 41 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK122591 Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
- Descendant · cites it directly · 13 of its ownK123978 Capstone L Spinal SystemMedtronic Sofamor Danek USA · 2013
- Descendant · 2 generations on · 6 of its ownK133645 Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal…Medtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK122591 Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA · 2013 · cites it directly13descendants
- K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on6descendants
- K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · 2 generations on5descendants
- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · 3 generations on4descendants
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −1 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| 0 (this device) | K122591 | Clydesdale Spinal System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| +1 | K123978 | Capstone L Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| +2 | K133645 | Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System… | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +2 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +3 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
| +2 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 MAX? 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? (1)
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 |
|---|---|---|---|
| * | K113528 | Clydesdale (R) Spinal SystemSummary page 2…ject system has the same indications, intended use and fundamental scientific technology as the previously FDA cleared predicate; CLYDESDALE9 Spinal System K1 13528 (S.F. 12/20/2011). There has been no design, material, indication, sterilization changes to the previously cleared CLYDESD… | 2011 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123978 | Capstone L Spinal System | 2013 | 13 |
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 28 years and passes through 10 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 41 ancestors have a recall of any class.
- Of its descendants, K123978 (Medtronic Sofamor Danek USA, 2013) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K113528.
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. 2012, 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 CLYDESDALE® 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 CLYDESDALE® 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.…
Read the full statement (117 words)
The CLYDESDALE® 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 CLYDESDALE® 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/K122591 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122591: Clydesdale Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122591
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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