510(k) · Cleared
ClearedSaphyre Bipolar Ablation Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 23, 2003 as substantially equivalent to K000691 (Oratec Interventions, Inc., 2000) and 2 other predicates after a 23-day review. Its family tree reaches back 1 generation to 1999. 19 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K991218 (1999). 3 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- This deviceK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- Descendant · 2 generations on · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
- Descendant · 2 generations on · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- Descendant · 3 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
- Descendant · 3 generations on · 4 of its ownK170827 INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005 · cites it directly17descendants
- K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · 2 generations on7descendants
- K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · 2 generations on5descendants
- K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 3 generations on4descendants
- K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| 0 (this device) | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| +1 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| +2 | K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016 | — |
| +2 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| +3 | K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018 | — |
| +3 | K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K000691 | Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels…Summary page 1…urgery could include 8 variety of procedures. I , - - Predicare Device(s) Indication for Usee: Vulcan Elecrrosurgicat Probes K000691,cIeared May 15,2000 AnhroCare ArthroWands KO1 1083, cleared June 28,2001… | 2000 |
| * | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand | 2001 |
| * | K991218 | Oratec Bipolar Ablation ProbesSummary page 1…AnhroCare ArthroWands KO1 1083, cleared June 28,2001 4 Design: Bipolar Ablation Probes K991218, cleared September 13. 1999 Smith & Ncphcw Bipolar Ablauon Probes… | 1999 |
What descends from it? (19)
See all 192 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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures, as listed…
Read the full statement (130 words)
The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures, as listed in the table below.
All Joints: Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy, Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of Blood Vessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty.
Knee: Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, Lateral Release, Labral Tear.
Shoulder: Acromioplasty, Rotator Cuff Debridement, Subacromial Decompression CA Ligament Resection, and Capsular Release.
Wrist: Triangular Fibrocartilage (TFC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031371: Saphyre Bipolar Ablation Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031371
Report an extraction error
Are you the manufacturer?
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