510(k) · Cleared
ClearedNuvasive Guided Spinal Arthroscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · HRX Arthroscope
Cleared on Oct 5, 1999 after a 245-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 5, 1999
- Review
- 245 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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What was it cleared against? (8)
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 |
|---|---|---|---|
| * | — | INCLUSIVE™ Endoscope and Micro-Endo™ Instruments (Sofamor Danek) Named without a submission number | |
| * | — | PercScope™ (Clarus Medical) Named without a submission number | |
| * | — | Percutaneous Discectomy System (Richard Wolf Medical) Named without a submission number | |
| * | — | Gouda Stereotactic Frame (neurological Devices) Named without a submission number | |
| * | — | Stereoguide Breast Biopsy System (Lorad Corp.) Named without a submission number | |
| * | — | ABBI™ System and Auto Suture® Dilating Cannula (U.S. Surgical Corp.) Named without a submission number | |
| * | — | Mammotome Multi-Probe (Biopsys Medical) Named without a submission number | |
| * | — | ENDOPATH™ Trocar Sleeve with Dilating Obturator (Ethicon) Named without a submission number |
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.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical…
Read the full statement (126 words)
The NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with the NuVasive Spinal Arthroscope, but may be used with other arthroscopes having a minimum working length of 400 mm, an outer sheath diameter of 5.0 mm, and which are indicated for use in 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/K990324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990324: Nuvasive Guided Spinal Arthroscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990324
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026