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 Apr 24, 2008 as substantially equivalent to P970015 (Sofamor Danek, 1999) and 4 other predicates after a 153-day review. Its family tree reaches back 9 generations to 1984. 1 of the 1,131 devices in its family, counting itself, has a Class I recall. 1,103 later devices descend from it.
- Decided
- Apr 24, 2008
- Review
- 153 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K841189 (1984). 27 ancestors in all. 1,103 later devices descend from it, 41 citing it directly. 1 of the 1,131 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · cites it directly · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 838 of its ownK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 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 · cites it directly · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
Showing 5 of 1,103 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 1,103 · See all- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly1,008descendants
- K094025Crescent Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly838descendants
- K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly808descendants
- K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009 · cites it directly796descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly761descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +1 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| +1 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 15 | 0 |
| 2013 | 20 | 0 |
| 2014 | 26 | 0 |
| 2015 | 31 | 0 |
| 2016 | 53 | 0 |
| 2017 | 78 | 0 |
| 2018 | 74 | 0 |
| 2019 | 94 | 0 |
| 2020 | 94 | 0 |
| 2021 | 91 | 1 |
| 2022 | 95 | 0 |
| 2023 | 123 | 0 |
| 2024 | 117 | 0 |
| 2025 | 97 | 0 |
| 2026 | 82 | 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? (5)
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 |
|---|---|---|---|
| * | P970015 | Inter Fix Threaded Fusion DeviceSummary page 2…subject CAPSTONE® Spinal System is substantially equivalent to five recently down classified interbody cages, the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threade… | 1999 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 2…recently down classified interbody cages, the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage… | 1996 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 2…ed Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT INTERVERTEBRAL BO… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 2…9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies, SE 1… | 1999 |
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 2…d Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies, SE 10/11/07). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2007 |
What descends from it? (1,103)
See all 1,10341 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 |
| K094025 | Crescent Spinal System | 2010 | 838 |
| K110543 | Crescent (R) Spinal System Titanium | 2011 | 808 |
| K090353 | Perimeter Interbody Fusion Device | 2009 | 796 |
| K120368 | Capstone Control Spinal System | 2012 | 761 |
| K121760 | Capstone Spinal System | 2012 | 723 |
| K082342 | Modification to Capstone Spinal System | 2008 | 716 |
| K082732 | Modification to: Capstone Spinal System | 2008 | 710 |
| K131082 | Interform Interbody Cage System | 2013 | 595 |
| K113528 | Clydesdale (R) Spinal System | 2011 | 361 |
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 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K100175 (Medtronic Sofamor Danek, 2010) has gone furthest, with 1,008 descendants of its own.
- 18 other devices also cite its predicate P970015.
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 CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients 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…
Read the full statement (129 words)
The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients 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 an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. 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/K073291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073291: 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/K073291
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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