Cleared Traditional

K990524 - E9000 SYSTEM

K990524 is the FDA 510(k) clearance for E9000 SYSTEM by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K990524 · Linvatec Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 1999
Decision
146d
Days
Class 2
Risk

K990524 is an FDA 510(k) clearance for the E9000 SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on July 15, 1999 after a review of 146 days - within the typical 510(k) review window.

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 Linvatec Corp. devices

Submission Details

510(k) Number K990524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1999
Decision Date July 15, 1999
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 361
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K990524.
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
K990324 · Nuvasive, Inc. · Oct 1999
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
K992782 · Nuvasive, Inc. · Oct 1999
RIWO DRIVE GENERATOR
K984304 · Richard Wolf Medical Instruments Corp. · Aug 1999
KSEA EPIDUROSCOPE
K991051 · KARL STORZ Endoscopy-America, Inc. · Jun 1999
ABLATOR ELECTRODE
K983652 · Linvatec Corp. · Mar 1999
KSEA C-MOUNT ARTHROSCOPES
K983142 · Karl Storz Endoscopy · Dec 1998