Cleared Traditional

MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE (K915139) - FDA 510(k) Clearance

Class I Orthopedic device.

K915139 · Micro Surgical Instruments Corp. · Orthopedic device

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Feb 1992

Decision

84d

Days

Class 1

Risk

K915139 is an FDA 510(k) clearance for the MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on February 5, 1992 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Micro Surgical Instruments Corp. devices

Submission Details

510(k) Number	K915139 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1991
Decision Date	February 05, 1992
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

38d faster than avg

Panel avg: 122d · This submission: 84d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 878.4820

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K915139.

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Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K915139

Micro Surgical Instruments Corp.

Valencia, CA · US

MOE KHOSRAVI

Regulatory profile

15 submissions 13 cleared

87% clearance rate · Active in Orthopedic

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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