Cleared Traditional

K993021 - METRX SYSTEM

K993021 is an FDA 510(k) clearance for METRX SYSTEM, manufactured by Surgical Navigation Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K993021 · Surgical Navigation Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
63d
Days
Class 2
Risk

K993021 is an FDA 510(k) clearance for the METRX SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Navigation Technologies, Inc. devices

FDA 510(k) Submission Details - K993021

510(k) Number K993021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1999
Decision Date November 10, 1999
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 547
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K993021.
ARTHRO-SURGIMAT-A103
K000153 · W.O.M. World of Medicine GmbH · Feb 2000
AED ARTHROSCOPE
K991656 · National Advanced Endoscopy Devices, Inc. · Dec 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
K992621 · Advanced Diagnostics & Interventions · 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