Cleared Traditional

K994363 - INSTRUMENTS FOR MINIMALLY INVASIVE SPIN...

K994363 is the FDA 510(k) clearance for INSTRUMENTS FOR MINIMALLY INVASIVE SPIN... by Richard Wolf Medical Instruments Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K994363 · Richard Wolf Medical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
70d
Days
Class 2
Risk

K994363 is an FDA 510(k) clearance for the INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 6, 2000 after a review of 70 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K994363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date March 06, 2000
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 K994363.
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · United States Surgical, A Division of Tyco Healthc · Aug 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · Smith & Nephew, Inc. · Jun 2000
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · Richard Wolf Medical Instruments Corp. · Mar 2000
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · Richard Wolf Medical Instruments Corp. · Oct 1999
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
K990324 · Nuvasive, Inc. · Oct 1999