# K990324: Nuvasive Guided Spinal Arthroscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Oct 5, 1999 after 245 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) INCLUSIVE™ Endoscope and Micro-Endo™ Instruments (Sofamor Danek): named in the summary without a submission number
- (no number) PercScope™ (Clarus Medical): named in the summary without a submission number
- (no number) Percutaneous Discectomy System (Richard Wolf Medical): named in the summary without a submission number
- (no number) Gouda Stereotactic Frame (neurological Devices): named in the summary without a submission number
- (no number) Stereoguide Breast Biopsy System (Lorad Corp.): named in the summary without a submission number
- (no number) ABBI™ System and Auto Suture® Dilating Cannula (U.S. Surgical Corp.): named in the summary without a submission number
- (no number) Mammotome Multi-Probe (Biopsys Medical): named in the summary without a submission number
- (no number) ENDOPATH™ Trocar Sleeve with Dilating Obturator (Ethicon): named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K990324
Methodology: https://510kreport.com/methodology