Cleared Traditional

K992621 - ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES

K992621 is an FDA 510(k) clearance for ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES, manufactured by Advanced Diagnostics & Interventions. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K992621 · Advanced Diagnostics & Interventions · Orthopedic device
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Nov 1999
Decision
95d
Days
Class 2
Risk

K992621 is an FDA 510(k) clearance for the ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Advanced Diagnostics & Interventions (Redondo Beach, US). The FDA issued a Cleared decision on November 8, 1999 after a review of 95 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 Advanced Diagnostics & Interventions devices

FDA 510(k) Submission Details - K992621

510(k) Number K992621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1999
Decision Date November 08, 1999
Days to Decision 95 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
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 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K992621.
AED ARTHROSCOPE
K991656 · National Advanced Endoscopy Devices, Inc. · Dec 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
METRX SYSTEM
K993021 · Surgical Navigation Technologies, Inc. · Nov 1999
MASS (MICRO-ACCESS SPINE SYSTEM)
K992583 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · Oct 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · Richard Wolf Medical Instruments Corp. · Oct 1999
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
K993009 · Hydrocision, Inc. · Oct 1999