510(k) · Cleared
ClearedModification to Capstone 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 Sep 12, 2008 as substantially equivalent to K073291 (Medtronic Sofamor Danek USA, Inc., 2008) and 2 other predicates after a 28-day review. Its family tree reaches back 10 generations to 1984. 1 of the 761 devices in its family, counting itself, has a Class I recall. 716 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K841189 (1984). 44 ancestors in all. 716 later devices descend from it, 6 citing it directly. 1 of the 761 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 deviceK082342 Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 710 of its ownK082732 Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 2 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- Descendant · 3 generations on · 480 of its ownK141896 Coroent SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
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 deviceK082342 Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008
Showing 5 of 716 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 716 · See all- K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly710descendants
- K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 2 generations on709descendants
- K141896Coroent SystemNu Vasive, Incorporated · 2014 · 3 generations on480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 3 generations on469descendants
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) | K082342 | Modification to Capstone Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +1 | K082732 | Modification to: Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +2 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +3 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
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 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 22 | 0 |
| 2017 | 39 | 0 |
| 2018 | 45 | 0 |
| 2019 | 58 | 0 |
| 2020 | 74 | 0 |
| 2021 | 68 | 1 |
| 2022 | 71 | 0 |
| 2023 | 87 | 0 |
| 2024 | 91 | 0 |
| 2025 | 75 | 0 |
| 2026 | 65 | 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? (3)
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 1…ovided which demonstrated that the subject CAPSTONE® Spinal System devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08) as well as the VERTE-STACK® Spinal System (K043566 SE 01/07/05, K043561 SE 12/29/04). .ys V… | 2008 |
| * | K043566 | Modification to Verte-Stack Spinal SystemSummary page 1…em devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08) as well as the VERTE-STACK® Spinal System (K043566 SE 01/07/05, K043561 SE 12/29/04). .ys V C 5 s DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2005 |
| * | K043561 | Modification to Verte-Stack Spinal SystemSummary page 1…ntially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08) as well as the VERTE-STACK® Spinal System (K043566 SE 01/07/05, K043561 SE 12/29/04). .ys V C 5 s DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2004 |
What descends from it? (716)
See all 7166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082732 | Modification to: Capstone Spinal System | 2008 | 710 |
| K132926 | Velofixtm Interbody Fusion System | 2014 | 10 |
| K140864 | Veloxtm Interbody Fusion System | 2014 | 9 |
| K181048 | Neo Cage System TM | 2019 | 1 |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT… | 2020 | 0 |
| K191796 | Neo Cage System | 2019 | 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 · 6 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 9 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 44 ancestors have a recall of any class.
- Of its descendants, K082732 (Medtronic Sofamor Danek USA, Inc., 2008) has gone furthest, with 710 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. 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 interbody fusion 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…
Read the full statement (140 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 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 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/K082342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082342: Modification to 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/K082342
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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