Cleared Traditional

K912843 - FLEXMEDICS RETRACT ORTH PROBE

K912843 is an FDA 510(k) clearance for FLEXMEDICS RETRACT ORTH PROBE, manufactured by Flexmedics. The device is a Class 1 Orthopedic device with product code HXB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K912843 · Flexmedics · Orthopedic device
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Sep 1991
Decision
90d
Days
Class 1
Risk

K912843 is an FDA 510(k) clearance for the FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE. Classified as Probe (product code HXB), Class I - General Controls.

Submitted by Flexmedics (Minneapolis, US). The FDA issued a Cleared decision on September 24, 1991 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Flexmedics devices

FDA 510(k) Submission Details - K912843

510(k) Number K912843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date September 24, 1991
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HXB Device Classification - Class 1, General Controls

Product Code HXB Probe
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.

Regulatory Peers - HXB Probe

Devices cleared under the same product code (HXB) and FDA review panel - the closest regulatory comparables to K912843.
SURGICAL PROBE
K890227 · Kinetic Medical Products · Jan 1989
BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375
K873651 · Arthropedics, Inc. · Nov 1987
HOOK PROBE #TM-1376
K873652 · Arthropedics, Inc. · Nov 1987
SHUTT PRECISION PROBES
K840558 · Concept, Inc. · Apr 1984
GOLDEN RETRIEVERS OR SILVER RETRIEVERS
K800444 · Instrument Makar, Inc. · Mar 1980
ACUFEX PROBES
K800274 · Acufex Microsurgical, Inc. · Feb 1980