Cleared Traditional

K990324 - NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM

K990324 is an FDA 510(k) clearance for NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K990324 · Nuvasive, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
245d
Days
Class 2
Risk

K990324 is an FDA 510(k) clearance for the NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 5, 1999 after a review of 245 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuvasive, Inc. devices

FDA 510(k) Submission Details - K990324

510(k) Number K990324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1999
Decision Date October 05, 1999
Days to Decision 245 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 122d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K990324.
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
METRX SYSTEM
K993021 · Surgical Navigation Technologies, Inc. · Nov 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · Richard Wolf Medical Instruments Corp. · Oct 1999
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
K992782 · Nuvasive, Inc. · Oct 1999
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992876 · Mitek Products · Sep 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · Endius, Inc. · Aug 1999