510(k) Report

510(k) · Cleared

Cleared

Perimeter C Spinal System

K132584510(k) TraditionalCleared Dec 4, 2013110-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. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Dec 4, 2013 as substantially equivalent to K100967 (Medtronic Sofamor Danek USA, Inc., 2011) and 4 other predicates after a 110-day review. Its family tree reaches back 14 generations to 2001. 119 later devices descend from it.

Decided
Dec 4, 2013
Review
110 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
5

Its longest line of descent runs back 14 generations to K003155 (2001). 90 ancestors in all, the oldest K792352 (1979). 119 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2002: 6 other ancestors2001: 8 other ancestors2010: 2 other ancestors2009: 5 other ancestors2004: 14 other ancestors2008: 10 other ancestors2007: 5 other ancestors2006: 3 other ancestors2005: 4 other ancestors2003: 9 other ancestors1999: 2 other ancestors1996: 2 other ancestors2000: 1 other ancestor1984: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2016: 2 descendants cleared2014: 2 descendants cleared2019: 6 descendants cleared2017: 3 descendants cleared2018: 2 descendants cleared2020: 6 descendants cleared2024: 23 descendants cleared2021: 9 descendants cleared2023: 16 descendants cleared2026: 18 descendants cleared2025: 26 descendants cleared2022: 6 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 · 2010K100967 · Perimeter C Spinal System · Medtronic Sofamor Danek USA, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 20 other ancestors4 generations back: 14 other ancestors5 generations back: 16 other ancestors6 generations back: 10 other ancestors7 generations back: 4 other ancestors8 generations back: 2 other ancestors9 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 16 descendants4 generations forward: 24 descendants5 generations forward: 27 descendants6 generations forward: 22 descendants7 generations forward: 14 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant K100967 · Perimeter C Spinal System · Medtronic Sofamor Danek USA, Inc. · 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. · 2001−10−50+5
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations between
  3. 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  4. 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  5. 1 generation backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  6. This deviceK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  7. Descendant · cites it directly · 110 of its ownK153373 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System…Medtronic Sofamor Danek · 2016
  8. Descendant · 2 generations on · 94 of its ownK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
  9. Descendant · 3 generations on · 60 of its ownK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
  10. Descendant · 4 generations on · 39 of its ownK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
  11. Descendant · 2 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
Show all 14 generations
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 13 generations backK012254 VBROsteotech, Inc. · 2001
  3. 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  14. 1 generation backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  15. This deviceK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013

Showing 5 of 119 descendants. See all descendants

Descendants cleared per year

2014: 22016: 22017: 32018: 22019: 62020: 62021: 92022: 62023: 162024: 232025: 262026: 18
2014high 26 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 119 · See all
  • K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek · 2016 · cites it directly110descendants
  • K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018 · 2 generations on94descendants
  • K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019 · 3 generations on60descendants
  • K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2021 · 4 generations on39descendants
  • K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 2 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−13K012254VBROsteotech, Inc.2001—
−12K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−9K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−5K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−4K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−3K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010—
−1K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—
0 (this device)K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
+1K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK…Medtronic Sofamor Danek2016—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.2018—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation2019—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo…SeaSpine Orthopedics Corporation2021—
+2K180909REVEL SpacersGlobus Medical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199620
199810
199920
200010
200180
200260
200390
2004140
200540
200630
200750
2008100
200950
201020
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201620
201730
201820
201960
202060
202190
202260
2023160
2024230
2025260
2026180
FIG. 1 — Lineage of K132584, 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 ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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
*K100967Perimeter C Spinal System
Summary page 2
…aim Substantial Equivalence: In order to demonstrate substantial equivalence to legally marketed predicate device(s), PERIMETER® C Spinal System (K 100967. S.E. 08/05/2011) is used as the primary predicate in terms of indications for use, intended use, fundamental scientific…
Medtronic Sofamor Danek USA, Inc.2011—
*P000028Affinity (TM) Cage System
Summary page 2
…for use, intended use, fundamental scientific technology. and performance and technological characteristics. AFFINITY®D Anterior Cervical Cage System (P000028. Approval Date 06/13/2002. Down Classified to aClass 11special control. Date of Final Order 06/12/2007), BAlK/C®…
Medtronic Sofamor Danek USA, Inc.2002—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 2
…28. Approval Date 06/13/2002. Down Classified to aClass 11special control. Date of Final Order 06/12/2007), BAlK/C® Cervical Interbody Fusion System (P980048, Approval Date 10/06/2004, Down Classified to a Class 11 special control. Date of Final Order 06/…
Sulzer Spine-Tech2001—
*K100214Cornerstone PSR Cervical Interbody Fusion Device
Summary page 2
…proval Date 10/06/2004, Down Classified to a Class 11 special control. Date of Final Order 06/12/2007). CORNERSTONE® PSR Spinal System (K 100214, S.E. 06/25/2010), and ANATOMIC PEEK T M Spinal System (KI 12444, S.E. 11/16/2011) are additionally used as predicates…
Medtronic Sofamor Danek2010—
*K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011—

Also cleared against K100967: 3 other devices →

What descends from it? (119)

See all 119

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

NumberDeviceApplicantDecidedDescendants
K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110
K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411
K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160

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 12 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 6 of the 90 ancestors have a recall of any class.
  • Of its descendants, K153373 (Medtronic Sofamor Danek, 2016) has gone furthest, with 110 descendants of its own.
  • 3 other devices also cite its predicate K100967.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

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 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.

Indications for use as stated in the FDA summary.

Also cleared against K100967

3 other devices cite the same predicate.

  • K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody DeviceMedtronic Sofamor Danek · 2016
  • K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
  • K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014

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 ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K132584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132584: Perimeter C 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/K132584

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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