Cleared Traditional

MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM (K994425) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994425 · Endius, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
48d
Days
Class 2
Risk

K994425 is an FDA 510(k) clearance for the MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 48 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 Endius, Inc. devices

Submission Details

510(k) Number K994425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date February 16, 2000
Days to Decision 48 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 122d · This submission: 48d
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 161
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K994425.
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · KARL STORZ Endoscopy-America, Inc. · Sep 2000
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
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
KSEA EPIDUROSCOPE
K991051 · KARL STORZ Endoscopy-America, Inc. · Jun 1999
DCI ENDOSCOPE
K983384 · KARL STORZ Endoscopy-America, Inc. · Nov 1998