510(k) · Cleared
ClearedCapstone 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 Dec 20, 2013 as substantially equivalent to K073291 (Medtronic Sofamor Danek USA, Inc., 2008) and 3 other predicates after a 23-day review. Its family tree reaches back 14 generations to 1984. 1 of the 417 devices in its family, counting itself, has a Class I recall. 344 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 23 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K841189 (1984). 72 ancestors in all. 344 later devices descend from it, 8 citing it directly. 1 of the 417 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 255 of its ownK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 191 of its ownK142645 Avenue T TLIF CageLdr Spine USA, Inc. · 2015
- Descendant · 2 generations on · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 189 of its ownK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
Showing 5 of 344 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 344 · See all- K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly255descendants
- K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly228descendants
- K142645Avenue T TLIF CageLdr Spine USA, Inc. · 2015 · cites it directly191descendants
- K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on190descendants
- K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA · 2016 · 2 generations on189descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −2 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −1 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K133650 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K142645 | Avenue T TLIF Cage | Ldr Spine USA, Inc. | 2015 | — |
| +2 | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 13 | 0 |
| 2018 | 14 | 0 |
| 2019 | 25 | 0 |
| 2020 | 22 | 0 |
| 2021 | 30 | 1 |
| 2022 | 38 | 0 |
| 2023 | 41 | 0 |
| 2024 | 56 | 0 |
| 2025 | 48 | 0 |
| 2026 | 46 | 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? (4)
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 |
|---|---|---|---|
| * | K073291 | Capstone Spinal SystemSummary page 2…ific technology, and sterilization are not new and exist in other legally marketed devices. These predicates include CAPSTONE P, Spinal System (K073291, SE 4/24/2008 K123027. SE 07/25/2013; K121760. SE 08/29/2012) and CAPSTONE CONTROLTM" Spinal System (… | 2008 |
| * | K123027 | Capstone (R) Spinal SystemSummary page 2…erilization are not new and exist in other legally marketed devices. These predicates include CAPSTONE P, Spinal System (K073291, SE 4/24/2008 K123027. SE 07/25/2013; K121760. SE 08/29/2012) and CAPSTONE CONTROLTM" Spinal System (K 120368, SE 04/09/20 12). ===… | 2013 |
| * | K121760 | Capstone Spinal SystemSummary page 2…n other legally marketed devices. These predicates include CAPSTONE P, Spinal System (K073291, SE 4/24/2008 K123027. SE 07/25/2013; K121760. SE 08/29/2012) and CAPSTONE CONTROLTM" Spinal System (K 120368, SE 04/09/20 12).… | 2012 |
| * | K120368 | Capstone Control Spinal SystemSummary page 2…TONE P, Spinal System (K073291, SE 4/24/2008 K123027. SE 07/25/2013; K121760. SE 08/29/2012) and CAPSTONE CONTROLTM" Spinal System (K 120368, SE 04/09/20 12). K1 33650 - Page 3 of 3… | 2012 |
What descends from it? (344)
See all 3448 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | 2015 | 255 |
| K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | 2015 | 228 |
| K142645 | Avenue T TLIF Cage | 2015 | 191 |
| K153621 | Juliet® Ti | 2016 | 75 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT… | 2020 | 0 |
| K181899 | Roccia® Plif | 2018 | 0 |
| K180071 | STYLO Interbody Fusion Device | 2018 | 0 |
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 29 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 72 ancestors have a recall of any class.
- Of its descendants, K151128 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 255 descendants of its own.
- 40 other devices also cite its predicate K073291.
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. 2013, 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 indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. 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 be skeletally mature and have had six…
Read the full statement (167 words)
The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. 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 be skeletally mature and have had six months of nonoperative treatment.
Additionally, the CAPSTONE® Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
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. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133650: Capstone 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/K133650
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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