510(k) · Cleared
ClearedPerimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter 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 Jan 3, 2014 as substantially equivalent to K100967 (Medtronic Sofamor Danek USA, Inc., 2011) and 6 other predicates after a 37-day review. Its family tree reaches back 15 generations to 2001. 6 later devices descend from it.
- Decided
- Jan 3, 2014
- Review
- 37 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K003155 (2001). 127 ancestors in all, the oldest K792352 (1979). 6 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- This deviceK133645 Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal…Medtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · Recalled
- Descendant · 3 generations on · 0 of its ownK253577 IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025
- Descendant · 2 generations on · 0 of its ownK251431 FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK230936 Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- This deviceK133645 Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal…Medtronic Sofamor Danek USA, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · cites it directly4descendants
- K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · 2 generations on1descendant
- K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025 · 3 generations on0descendants
- K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025 · 2 generations on0descendants
- K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −5 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −2 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −1 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K133645 | Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System… | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +2 | K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024 | 2 |
| +3 | K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025 | — |
| +2 | K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025 | — |
| +2 | K230936 | Anatomic PEEK™ Cervical Fusion System with Nanotechnology | Nanovis, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 16 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 16 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K100967 | Perimeter C Spinal SystemSummary page 5…edicates. The subject devices are substantially equivalent to the devices and 51 0(k)s listed below: a. PERIMETER® C Spinal System (PEEK) K100967 August 51h, 2011 K133645 - Page 6 of 7… | 2011 |
| * | K073291 | Capstone Spinal SystemSummary page 6…=== K133645 - Page 6 of 7 b. CAPSTONE® PEEK Spinal System Implants * K073291 April 241h, 2008 * K121760 August 29th, 2012 * K123027 July 25th, 2013 c. CAPSTONE® L Sp… | 2008 |
| * | K121760 | Capstone Spinal SystemSummary page 6…K133645 - Page 6 of 7 b. CAPSTONE® PEEK Spinal System Implants * K073291 April 241h, 2008 * K121760 August 29th, 2012 * K123027 July 25th, 2013 c. CAPSTONE® L Spinal System Implants(PEEK)… | 2012 |
| * | K123027 | Capstone (R) Spinal SystemSummary page 6…age 6 of 7 b. CAPSTONE® PEEK Spinal System Implants * K073291 April 241h, 2008 * K121760 August 29th, 2012 * K123027 July 25th, 2013 c. CAPSTONE® L Spinal System Implants(PEEK) * K123978 April 9th, 2013 d. PERIME… | 2013 |
| * | K123978 | Capstone L Spinal SystemSummary page 6…l 241h, 2008 * K121760 August 29th, 2012 * K123027 July 25th, 2013 c. CAPSTONE® L Spinal System Implants(PEEK) * K123978 April 9th, 2013 d. PERIMETER® Interbody Fusion Device (PEEK) Implants * K090353 September 29thi, 2009… | 2013 |
| * | K090353 | Perimeter Interbody Fusion DeviceSummary page 6…c. CAPSTONE® L Spinal System Implants(PEEK) * K123978 April 9th, 2013 d. PERIMETER® Interbody Fusion Device (PEEK) Implants * K090353 September 29thi, 2009 e. PEEK Interbody MRI Update (includes worst case for MRI for PEEK Interbody Devices)… | 2009 |
| * | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Summary page 5…vices and Other Items for Safety in the Magnetic Resonance Environment. The MRI safety labeling that is being proposed has previously been cleared by FDA in submission K122037 for the following PEEK Interbody Fusion Devices: " ANATOMIC PEEK Cervical Fusion System *… | 2013 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 10 of the 127 ancestors have a recall of any class.
- Of its descendants, K192502 (Medtronic Sofamor Danek USA, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K100967.
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. 2014, 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 PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root…
Read the full statement (506 words)
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
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 non-operative treatment.
Additionally, the CAPSTONE® Spinal System is indicated 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.
The CAPSTONE® L 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 CAPSTONE® L 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 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 non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
The PERIMETER® Interbody Fusion Device 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 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 non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133645: Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter 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/K133645
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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