Cleared Traditional

K830456 - STAPLE INSERTER-EXTRACTOR FOR ARTHROS

K830456 is an FDA 510(k) clearance for STAPLE INSERTER-EXTRACTOR FOR ARTHROS, manufactured by Instrument Makar, Inc.. The device is a Class 1 Orthopedic device with product code HXJ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K830456 · Instrument Makar, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
28d
Days
Class 1
Risk

K830456 is an FDA 510(k) clearance for the STAPLE INSERTER-EXTRACTOR FOR ARTHROS. Classified as Staple Driver (product code HXJ), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 28 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 Instrument Makar, Inc. devices

FDA 510(k) Submission Details - K830456

510(k) Number K830456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1983
Decision Date March 09, 1983
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

HXJ Device Classification - Class 1, General Controls

Product Code HXJ Staple Driver
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.