Cleared Traditional

K963367 - RMS K-WIRE

K963367 is an FDA 510(k) clearance for RMS K-WIRE, manufactured by Rms Div.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K963367 · Rms Div. · Orthopedic device
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Oct 1996
Decision
64d
Days
Class 2
Risk

K963367 is an FDA 510(k) clearance for the RMS K-WIRE. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Rms Div. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1996 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Rms Div. devices

FDA 510(k) Submission Details - K963367

510(k) Number K963367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date October 30, 1996
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 131
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K963367.
BIORIGID NAIL TIBIA
K970013 · Aap GmbH and Co. Betriebs KG · Mar 1997
ACUMED TENSION BAND PIN
K964500 · Acu Med, Inc. · Dec 1996
BLOCK STOP WIRES
K964087 · Ferguson Medical · Nov 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522 · Synvasive Technology, Inc. · Sep 1996
NANCY NAIL
K960642 · Landos, Inc. · May 1996
K-WIRE
K960482 · American Medical Specialties, Inc. · Apr 1996