510(k) · Cleared
ClearedCORUS Spinal System-X
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 Oct 15, 2021 as substantially equivalent to K190201 (Providence Medical Technology, Inc., 2019) and 1 other predicate after a 57-day review. Its family tree reaches back 8 generations to 1992. 5 later devices descend from it.
- Decided
- Oct 15, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K922881 (1992). 42 ancestors in all, the oldest K844131 (1984). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
- 7 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
- 6 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
- 5 generations backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
- 4 generations backK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- 3 generations backK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- 2 generations backK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
- 1 generation backK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
- This deviceK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK260329 Ion-C Navigation InstrumentsSurGenTec, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK262121 Ion-L Navigated InstrumentsSurGenTec, LLC · 2026
- Descendant · cites it directly · 0 of its ownK251060 CORUS™ Navigation System-GXProvidence Medical Technology, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
Most influential descendants
Showing 5 of 5 · See all- K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024 · cites it directly4descendants
- K260329Ion-C Navigation InstrumentsSurGenTec, LLC · 2026 · 2 generations on1descendant
- K262121Ion-L Navigated InstrumentsSurGenTec, LLC · 2026 · 3 generations on0descendants
- K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc. · 2025 · cites it directly0descendants
- K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922881 | Clarus Models 1100, 1101, 1102, 1103 Laser Disc | Clarus Medical Systems, Inc. | 1992 | 1 |
| −7 | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser… | Clarus Medical, LLC | 2002 | — |
| −6 | K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… | Clarus Medical, LLC | 2004 | 1 |
| −5 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
| −4 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| −3 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| −2 | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
| −1 | K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | 2019 | — |
| 0 (this device) | K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | 2021 | — |
| +1 | K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024 | — |
| +2 | K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026 | — |
| +3 | K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026 | — |
| +1 | K251060 | CORUS™ Navigation System-GX | Providence Medical Technology, Inc. | 2025 | — |
| +2 | K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K190201 | CORUS Spinal SystemSummary page 4…litation Devices Panel Primary Predicate Device: Providence Medical Technology, Inc. CORUS™ Spinal System (K190201) Secondary Predicate Device: Vertos Medical, Inc. Vertos medical mil… | 2019 |
| * | K093062 | Vertos Medical Mild Device KitSummary page 4…S™ Spinal System (K190201) Secondary Predicate Device: Vertos Medical, Inc. Vertos medical mild™ Device Kit (K093062) Device Information A. Device Description The CORUS™ Spinal System‐X is a set of instruments indicated for p… | 2010 |
What descends from it? (5)
2 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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K240625 (Providence Medical Technology, Inc., 2024) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
For Cervical Fusion:
CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
For Lumbar Fusion:
CORUSTM Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212636: CORUS Spinal System-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212636
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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