510(k) · Cleared
ClearedDTRAX Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Medical Technology, Inc. · HRX Arthroscope
Cleared on May 18, 2018 as substantially equivalent to K093062 (X-Sten Corp., 2010) after a 45-day review. Its family tree reaches back 6 generations to 1992. 7 later devices descend from it.
- Decided
- May 18, 2018
- Review
- 45 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922881 (1992). 40 ancestors in all, the oldest K844131 (1984). 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
- 5 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
- 4 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
- 3 generations backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
- 2 generations backK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- 1 generation backK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- This deviceK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK260329 Ion-C Navigation InstrumentsSurGenTec, LLC · 2026
- Descendant · 5 generations on · 0 of its ownK262121 Ion-L Navigated InstrumentsSurGenTec, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · cites it directly6descendants
- K212636CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021 · 2 generations on5descendants
- K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024 · 3 generations on4descendants
- K260329Ion-C Navigation InstrumentsSurGenTec, LLC · 2026 · 4 generations on1descendant
- K262121Ion-L Navigated InstrumentsSurGenTec, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922881 | Clarus Models 1100, 1101, 1102, 1103 Laser Disc | Clarus Medical Systems, Inc. | 1992 | 1 |
| −5 | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser… | Clarus Medical, LLC | 2002 | — |
| −4 | K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… | Clarus Medical, LLC | 2004 | 1 |
| −3 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
| −2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| −1 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| 0 (this device) | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
| +1 | K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | 2019 | — |
| +2 | K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | 2021 | — |
| +3 | K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024 | — |
| +4 | K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026 | — |
| +5 | K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K093062 | Vertos Medical Mild Device KitSummary page 4…Orthopaedic and Rehabilitation Devices Panel Primary Predicate Device: Vertos Medical, Inc. Vertos Medical mild® Device Kit (K093062) Reference Devices: Dyonics, Inc. The Arthrofile (K812506) Transcor… | 2010 |
| † | K812506 | The Arthrofile | 1981 |
| † | K113352 | Transcorp Spinal Access System | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190201 | CORUS Spinal System | 2019 | 6 |
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 26 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 40 ancestors have a recall of any class.
- Of its descendants, K190201 (Providence Medical Technology, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K093062.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DTRAX® Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180876: DTRAX Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180876
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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