Cleared Traditional

MASS (MICRO-ACCESS SPINE SYSTEM) (K992583) - FDA 510(k) Clearance

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

K992583 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
88d
Days
Class 2
Risk

K992583 is an FDA 510(k) clearance for the MASS (MICRO-ACCESS SPINE SYSTEM). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Omni-Tract Surgical, Div. Minn. Scientific, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 29, 1999 after a review of 88 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 Omni-Tract Surgical, Div. Minn. Scientific, Inc. devices

Submission Details

510(k) Number K992583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date October 29, 1999
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K992583.
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · Richard Wolf Medical Instruments Corp. · Mar 2000
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363 · 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
RIWO DRIVE GENERATOR
K984304 · Richard Wolf Medical Instruments Corp. · Aug 1999
KSEA EPIDUROSCOPE
K991051 · KARL STORZ Endoscopy-America, Inc. · Jun 1999