Cleared Traditional

K800731 - MENISCAL SAW

K800731 is an FDA 510(k) clearance for MENISCAL SAW, manufactured by Stainless Mfg., Inc.. The device is a Class 1 Orthopedic device with product code HXP cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K800731 · Stainless Mfg., Inc. · Orthopedic device
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Apr 1980
Decision
7d
Days
Class 1
Risk

K800731 is an FDA 510(k) clearance for the MENISCAL SAW. Classified as Instrument, Bending Or Contouring (product code HXP), Class I - General Controls.

Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Stainless Mfg., Inc. devices

FDA 510(k) Submission Details - K800731

510(k) Number K800731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1980
Decision Date April 08, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 122d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

HXP Device Classification - Class 1, General Controls

Product Code HXP Instrument, Bending Or Contouring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.