510(k) Report

510(k) · Cleared

Cleared

Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament Chisels

K000691510(k) TraditionalCleared May 4, 200065-day reviewClass II21 CFR 888.1100

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

Oratec Interventions, Inc. · HRX Arthroscope

Cleared on May 4, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided
May 4, 2000
Review
65 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
0

21 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2014: 2 descendants cleared2005: 1 descendant cleared2004: 1 descendant cleared2016: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2009: 2 descendants cleared2008: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2012: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared2022: 2 descendants cleared200020052010201520202025
  1. This deviceK000691 Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan…Oratec Interventions, Inc. · 2000
  2. Descendant · cites it directly · 19 of its ownK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
  3. Descendant · 2 generations on · 17 of its ownK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
  4. Descendant · 3 generations on · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
  5. Descendant · 3 generations on · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
  6. Descendant · 4 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12006: 12007: 12008: 12009: 22012: 12014: 22015: 12016: 12017: 12018: 12019: 12022: 22024: 12025: 12026: 1
2003high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 21 · See all
  • K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003 · cites it directly19descendants
  • K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005 · 2 generations on17descendants
  • K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · 3 generations on7descendants
  • K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · 3 generations on5descendants
  • K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000691Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament…Oratec Interventions, Inc.2000—
+1K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc.2003—
+2K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments2005—
+3K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems2016—
+3K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments2006—
+4K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200610
200710
200810
200920
201210
201420
201510
201610
201710
201810
201910
202220
202410
202510
202610
FIG. 1 — Lineage of K000691, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc.200319
K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140

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?

  • Of its descendants, K031371 (Smith & Nephew, Inc., 2003) has gone furthest, with 19 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

More from Oratec Interventions, Inc.

24 FDA decisions under this applicant name. See the company

  • K013622Nucleotomy Intradiscal CatheterOratec Interventions, Inc. · 2002
  • K003198Vulcan Tac Probes, Model 911XXXOratec Interventions, Inc. · 2001
  • K003893Vulcan Ablator Electrosurgical Probes, Vulcan Ligament Chisel Electrosurgical Probes, Model…Oratec Interventions, Inc. · 2001
  • K992805Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)Oratec Interventions, Inc. · 2000
  • K994333Ora-50 Electrothermal System and AccessoriesOratec Interventions, Inc. · 2000

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https://510kreport.com/device/K000691 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000691: Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament Chisels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000691

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026