510(k) · Cleared
ClearedTELIGEN System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · HRX Arthroscope
Cleared on Oct 18, 2022 as substantially equivalent to K191579 (Viseon, Inc., 2019) and 1 other predicate after a 302-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Oct 18, 2022
- Review
- 302 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002764 (2000). 10 ancestors in all, the oldest K972768 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK002764 Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 2000
- 4 generations backK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- 3 generations backK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003 · Recalled
- 2 generations backK041233 Arthrojet XTHydrocision, Inc. · 2004
- 1 generation backK122861 XTOOLOuroboros Medical · 2012
- This deviceK213978 TELIGEN SystemMedos International SARL · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002764 | Hydrocision Arthrojet System with Cautery and Burr | Hydrocision, Inc. | 2000 | — |
| −4 | K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | 2002 | — |
| −3 | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models… | Hydrocision, Inc. | 2003 | 2 |
| −2 | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
| −1 | K122861 | XTOOL | Ouroboros Medical | 2012 | — |
| 0 (this device) | K213978 | TELIGEN System | Medos International SARL | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K191579 | Voyant SystemSummary page 4…21 CFR §888.1100 Classification Product and HRX – Orthopedic Panel Code D. Predicate Device Names Primary Predicate Device: Voyant System (K191579) – HRX Additional Predicate Devices: XTool™ MIS Discectomy Device (K122861) – HRX Reference device: OVS1 Vi… | 2019 |
| * | K122861 | XTOOLSummary page 4…e D. Predicate Device Names Primary Predicate Device: Voyant System (K191579) – HRX Additional Predicate Devices: XTool™ MIS Discectomy Device (K122861) – HRX Reference device: OVS1 Video System (K123359) – FCW, GCJ… | 2012 |
| † | K123359 | OVS1 Video System | 2012 |
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 22 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213978: TELIGEN System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213978
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