510(k) Report

510(k) · Cleared

Cleared

Capstone PTC Spinal System, Clydesdale PTC Spinal System

K133205510(k) TraditionalCleared Mar 13, 2014146-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Mar 13, 2014 as substantially equivalent to K073291 (Medtronic Sofamor Danek USA, Inc., 2008) and 4 other predicates after a 146-day review. Its family tree reaches back 15 generations to 2001. 124 later devices descend from it.

Decided
Mar 13, 2014
Review
146 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
5

Its longest line of descent runs back 15 generations to K003155 (2001). 127 ancestors in all, the oldest K792352 (1979). 124 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 4 other ancestors2011: 8 other ancestors2008: 16 other ancestors2010: 5 other ancestors2009: 8 other ancestors2007: 10 other ancestors2003: 11 other ancestors1999: 3 other ancestors1996: 2 other ancestors2006: 3 other ancestors2005: 6 other ancestors2004: 16 other ancestors2002: 6 other ancestors2001: 8 other ancestors2000: 1 other ancestor1984: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2017: 4 descendants cleared2020: 5 descendants cleared2018: 2 descendants cleared2014: 1 descendant cleared2019: 5 descendants cleared2022: 14 descendants cleared2021: 9 descendants cleared2026: 26 descendants cleared2024: 25 descendants cleared2023: 10 descendants cleared2025: 23 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×3: 3 generations cleared close together, K040536 (2004), K041556 (2004), K043561 (2004) ×3: 3 generations cleared close together, K060719 (2006), K062133 (2006), K070173 (2007) K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K100214 · Cornerstone PSR Cervical Interbody Fusion Device · Medtronic Sofamor Danek · 2010K111264 · Cornerstone (R) PSR Cervical Fusion System · Medtronic Sofamor Danek USA · 2011K122037 · Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst · Medtronic Sofamor Danek, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 23 other ancestors3 generations back: 21 other ancestors4 generations back: 26 other ancestors5 generations back: 22 other ancestors6 generations back: 13 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 12 descendants3 generations forward: 16 descendants4 generations forward: 32 descendants5 generations forward: 34 descendants6 generations forward: 19 descendants7 generations forward: 3 descendants K122037 · Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst · Medtronic Sofamor Danek, Inc. · 2013K111264 · Cornerstone (R) PSR Cervical Fusion System · Medtronic Sofamor Danek USA · 2011K100214 · Cornerstone PSR Cervical Interbody Fusion Device · Medtronic Sofamor Danek · 2010K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K070173 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2007K062133 · Modification to Verte-Stack Spinal System · Medtronic Spinal and Biologics Div · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−15−10−50+5
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations between
  3. 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  4. 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
  5. 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  6. This deviceK133205 Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  7. 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
  8. 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
  9. Descendant · 3 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
  10. Descendant · 4 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
  11. Descendant · 2 generations on · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
Show all 15 generations
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 14 generations backK012254 VBROsteotech, Inc. · 2001
  3. 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  14. 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
  15. 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  16. This deviceK133205 Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014

Showing 5 of 124 descendants. See all descendants

Descendants cleared per year

2014: 12017: 42018: 22019: 52020: 52021: 92022: 142023: 102024: 252025: 232026: 26
2014high 26 (2026) · low 0 (2015)2026

Most influential descendants

Showing 5 of 124 · See all
  • 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
  • K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 4 generations on81descendants
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · 2 generations on79descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−14K012254VBROsteotech, Inc.2001—
−13K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−12K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−10K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−6K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−5K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010—
−2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011—
−1K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System…Medtronic Sofamor Danek, Inc.2013—
0 (this device)K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
+1K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2017—
+2K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2019—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic…Titan Spine, Inc.2020—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199620
199810
199930
200010
200180
200260
2003110
2004160
200560
200630
2007100
2008160
200980
201050
201180
201240
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201740
201820
201950
202050
202190
2022140
2023100
2024250
2025230
2026260
FIG. 1 — Lineage of K133205, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K073291Capstone Spinal System
Summary page 3
…se and Spinal fundamental scientific technology as the predicate, CAPSTONE®& System (K073291, SE 4/24/2009 and K123027, SE 07/25/2013). The CLYDESDALE PTCTM Spinal System has the same indications for use and…
Medtronic Sofamor Danek USA, Inc.2008—
*K123027Capstone (R) Spinal System
Summary page 3
…Spinal fundamental scientific technology as the predicate, CAPSTONE®& System (K073291, SE 4/24/2009 and K123027, SE 07/25/2013). The CLYDESDALE PTCTM Spinal System has the same indications for use and fundamental scientific t…
Medtronic Sofamor Danek, Inc.2013—
*K113528Clydesdale (R) Spinal System
Our reading of the summary gave K110528, FDA’s number for Integra Led Surgical Headlight System (Integra LifeSciences Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CLYDESDALE® Spinal System”.
Medtronic Sofamor Danek USA, Inc.2011—
*K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…
Summary page 3
…l System has the same indications for use and fundamental scientific technology as the predicate, CLYDESDALE® Spinal System (KI 130528, SE 12/20/2011 and K122037, SE 3/22/2013). An additional predicate, Spinal Element's Lucent Ti-Bond Spinal System (K 110632, SE 5/23/2012),…
Medtronic Sofamor Danek, Inc.2013—
*K110632Lucent or Lucent Magnum
Summary page 3
…DALE® Spinal System (KI 130528, SE 12/20/2011 and K122037, SE 3/22/2013). An additional predicate, Spinal Element's Lucent Ti-Bond Spinal System (K 110632, SE 5/23/2012), is also being used to demonstrate that the commercially pure titanium coating is not new and currently ex…
Spinal Elements, Inc.20121

Also cleared against K073291: 40 other devices →

What descends from it? (124)

See all 124

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109
K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730
K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178
K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176
K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204
K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200
K173189Lumfuse TPPrecifit Medical, Ltd.20180
K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140

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 10 months on median.
  • 11 of the 127 ancestors have a recall of any class.
  • Of its descendants, K171689 (Medtronic Sofamor Danek USA, Inc., 2017) has gone furthest, with 109 descendants of its own.
  • 40 other devices also cite its predicate K073291.

How does its category compare?

All MAX devices

MAX 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

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The CAPSTONE PTCTM 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…

Read the full statement (291 words)

The CAPSTONE PTCTM 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 PTCTM 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 Food and Drug Administration (FDA) for use in the lumbar spine.

CLYDESDALE PTCTM Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTCTM 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.

Indications for use as stated in the FDA summary.

Also cleared against K073291

40 other devices cite the same predicate.

  • K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2024
  • K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
  • K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
  • K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
  • K201287Impulse Interbody Fusion SystemDegen Medical · 2020
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K133205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133205: Capstone PTC Spinal System, Clydesdale PTC 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/K133205

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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