510(k) · Cleared
ClearedCAPSTONE Spinal System, CLYDESDALE Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 6, 2015 as substantially equivalent to K133577 (Medtronic Sofamor Danek USA, Inc., 2014) and 1 other predicate after a 100-day review. Its family tree reaches back 15 generations to 1984. 1 of the 330 devices in its family, counting itself, has a Class I recall. 255 later devices descend from it.
- Decided
- Aug 6, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K841189 (1984). 74 ancestors in all. 255 later devices descend from it, 11 citing it directly. 1 of the 330 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 1 generation backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
- Descendant · 2 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 4 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 1 generation backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 255 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 255 · See all- K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly190descendants
- K161379ELSA SpacersGlobus Medical, Inc. · 2016 · 2 generations on155descendants
- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · cites it directly109descendants
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on108descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 3 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −4 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −2 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −1 | K133650 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +2 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 22 | 1 |
| 2022 | 29 | 0 |
| 2023 | 28 | 0 |
| 2024 | 48 | 0 |
| 2025 | 45 | 0 |
| 2026 | 42 | 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 |
|---|---|---|---|
| * | K133577 | Clydesdale (R) Spinal SystemSummary page 5…on Name(s): Intervertebral Body Fusion Device Product Code: MAX Predicate Devices: Primary Predicate: CLYDESDALE® Spinal System (K133577, SE 09/26/14) Class II, 21 CFR 888.3080, MAX; Additional Predicat… | 2014 |
| * | K133650 | Capstone Spinal SystemSummary page 5…tem (K133577, SE 09/26/14) Class II, 21 CFR 888.3080, MAX; Additional Predicate: CAPSTONE® Spinal System (K133650, SE 12/20/13) Class II, 21 CFR 888.3080, MAX Description: CLYDESDALE® Spinal System: The CLYDESD… | 2013 |
| † | K130177 | Anatomic Peek Cervical Fusion System | 2013 |
What descends from it? (255)
See all 25511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152277 | PIVOX (tm) Oblique Lateral Spinal System | 2015 | 190 |
| K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with… | 2017 | 109 |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | 2020 | 79 |
| K162212 | Divergence-L Anterior/Oblique Lumbar Fusion System | 2017 | 57 |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | 2021 | 55 |
| K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | 2017 | 8 |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT… | 2017 | 6 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
| K163422 | Shanghai Sanyou PEEK Cage System | 2017 | 3 |
| 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?
- The line of descent spans 31 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 74 ancestors have a recall of any class.
- Of its descendants, K152277 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 190 descendants of its own.
- 5 other devices also cite its predicate K133577.
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. 2015, 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 CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. When used for these indications, the CAPSTONE® Spinal…
Read the full statement (362 words)
The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. When used for these indications, the CAPSTONE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the CAPSTONE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.
The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
These patients should be skeletally mature and have had six months of nonoperative treatment.
The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral 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/K151128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151128: CAPSTONE Spinal System, 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/K151128
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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