510(k) Report

510(k) · Cleared

Cleared

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

K191788510(k) TraditionalCleared Mar 23, 2020264-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 23, 2020 as substantially equivalent to K073291 (Medtronic Sofamor Danek USA, Inc., 2008) and 9 other predicates after a 264-day review. Its family tree reaches back 17 generations to 2001.

Decided
Mar 23, 2020
Review
264 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
10

Its longest line of descent runs back 17 generations to K003155 (2001). 172 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 3 other ancestors2013: 5 other ancestors2012: 7 other ancestors2011: 10 other ancestors2010: 6 other ancestors2008: 23 other ancestors2007: 12 other ancestors2006: 5 other ancestors2005: 9 other ancestors1999: 4 other ancestors1996: 2 other ancestors2014: 1 other ancestor2009: 12 other ancestors2004: 19 other ancestors2003: 13 other ancestors2002: 8 other ancestors2001: 10 other ancestors2000: 1 other ancestor1984: 1 other ancestor1993: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestorReference device: K122037 · Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst · Medtronic Sofamor Danek, Inc. · 2013Reference device: K171689 · ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology · Medtronic Sofamor Danek USA, Inc. · 2017K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 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. · 2013K133205 · Capstone PTC Spinal System, Clydesdale PTC Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K172199 · ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium · Medtronic Sofamor Danek · 201719801990200020102020
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 22 other ancestors3 generations back: 32 other ancestors4 generations back: 38 other ancestors5 generations back: 32 other ancestors6 generations back: 16 other ancestors7 generations back: 6 other ancestors8 generations back: 1 other ancestor K172199 · ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium · Medtronic Sofamor Danek · 2017K133205 · Capstone PTC Spinal System, Clydesdale PTC Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122037 · 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
  1. Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 13 generations between
  3. 3 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  4. 2 generations backK133205 Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  5. 1 generation backK172199 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal…Medtronic Sofamor Danek · 2017
  6. This deviceK191788 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc. · 2020
Show all 17 generations
  1. Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 16 generations backK012254 VBROsteotech, Inc. · 2001
  3. 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 8 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 7 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 6 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 5 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  14. 4 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
  15. 3 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  16. 2 generations backK133205 Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 1 generation backK172199 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal…Medtronic Sofamor Danek · 2017
  18. This deviceK191788 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−16K012254VBROsteotech, Inc.2001—
−15K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−14K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−13K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−12K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−11K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−8K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−7K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−6K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010—
−4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011—
−3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System…Medtronic Sofamor Danek, Inc.2013—
−2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−1K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System…Medtronic Sofamor Danek2017—
0 (this device)K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System…Medtronic Sofamor Danek USA, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199310
199620
199810
199940
200010
2001100
200280
2003130
2004190
200590
200650
2007120
2008230
2009120
201060
2011100
201270
201350
201410
201530
FIG. 1 — Lineage of K191788, 2001–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (10)

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 6
…x 21 CFR 888.3080 Regulation Name and x Intervertebral Body Fusion Device Device Product Code: x MAX Predicate Devices: • Primary Predicate- K073291 CAPSTONE® Spinal System (S.E. 04/24/2008) Additional Predicates:…
Medtronic Sofamor Danek USA, Inc.2008—
*K082342Modification to Capstone Spinal System
Summary page 6
…Predicate- K073291 CAPSTONE® Spinal System (S.E. 04/24/2008) Additional Predicates: • Predicate 2- K082342 CAPSTONE® Spinal System (S.E. 09/12/2008) • Predicate 3- K082732 CAPSTONE® Spinal…
Medtronic Sofamor Danek2008—
*K082732Modification to: Capstone Spinal System
Summary page 6
…itional Predicates: • Predicate 2- K082342 CAPSTONE® Spinal System (S.E. 09/12/2008) • Predicate 3- K082732 CAPSTONE® Spinal System (S.E. 10/16/2008) • Predicate 4- K094025 CRESCENTTM Spinal…
Medtronic Sofamor Danek USA, Inc.2008—
*K094025Crescent Spinal System
Summary page 6
…(S.E. 09/12/2008) • Predicate 3- K082732 CAPSTONE® Spinal System (S.E. 10/16/2008) • Predicate 4- K094025 CRESCENTTM Spinal System (S.E. 04/26/2010) • Predicate 5- K110543 CRESCENT® Spinal…
Medtronic Sofamor Danek2010—
*K110543Crescent (R) Spinal System Titanium
Summary page 6
…(S.E. 10/16/2008) • Predicate 4- K094025 CRESCENTTM Spinal System (S.E. 04/26/2010) • Predicate 5- K110543 CRESCENT® Spinal System Titanium (S.E. 08/09/2011) • Predicate 6- K121760 CAPSTONE…
Medtronic Sofamor Danek USA, Inc.2011—
*K121760Capstone Spinal System
Summary page 6
…/26/2010) • Predicate 5- K110543 CRESCENT® Spinal System Titanium (S.E. 08/09/2011) • Predicate 6- K121760 CAPSTONE® Spinal System (S.E. 08/29/2012) • Predicate 7- K133205 CAPSTONE PTCTM…
Medtronic Sofamor Danek USA, Inc.2012—
*K133205Capstone PTC Spinal System, Clydesdale PTC Spinal System
Summary page 6
…(S.E. 08/09/2011) • Predicate 6- K121760 CAPSTONE® Spinal System (S.E. 08/29/2012) • Predicate 7- K133205 CAPSTONE PTCTM SPINAL SYSTEM, CLYDESDALE PTCTM SPINAL SYSTEM (S.E. 03/13/2014)…
Medtronic Sofamor Danek USA, Inc.2014—
*K133650Capstone Spinal System
Summary page 6
…33205 CAPSTONE PTCTM SPINAL SYSTEM, CLYDESDALE PTCTM SPINAL SYSTEM (S.E. 03/13/2014) • Predicate 8- K133650 CAPSTONE® Spinal System (S.E. 12/20/2013) • Predicate 9- K172199 ELEVATE™ Spinal…
Medtronic Sofamor Danek USA, Inc.2013—
*K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…
Summary page 6
…(S.E. 03/13/2014) • Predicate 8- K133650 CAPSTONE® Spinal System (S.E. 12/20/2013) • Predicate 9- K172199 ELEVATE™ Spinal System, CAPSTONE PTC™ Spinal System, CRESCENT™ Spinal System, CRESC…
Medtronic Sofamor Danek2017—
*K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
Summary page 6
…System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium (S.E. 09/19/2017) • Predicate 10- K150135 DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System (S.E. 06/11/2015)…
Medtronic Sofamor Danek USA, Inc.2015—
†K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013—
†K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017—

Also cleared against K073291: 40 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 6 companies; a new generation was cleared every 12 months on median.
  • 13 of the 172 ancestors have a recall of any class.
  • 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. 2020, 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™ 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 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 (678 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 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.

The CLYDESDALE PTC™ 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 CLYDESDALE PTC™ 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 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 a minimally invasive lateral approach.

The CRESCENT® 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 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 nonoperative treatment. These implants are to be used 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 CRESCENT Spinal System Titanium 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 are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use 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. Additionally, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCEL™ Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

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

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  • 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/K191788 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191788: CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191788

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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