Cleared Traditional

K961522 - KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN

K961522 is an FDA 510(k) clearance for KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN, manufactured by Synvasive Technology, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K961522 · Synvasive Technology, Inc. · Orthopedic device
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Sep 1996
Decision
154d
Days
Class 2
Risk

K961522 is an FDA 510(k) clearance for the KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Synvasive Technology, Inc. (El Dorado, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 154 days - an extended review 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: 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 Synvasive Technology, Inc. devices

FDA 510(k) Submission Details - K961522

510(k) Number K961522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date September 23, 1996
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
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 121
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K961522.
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
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385 · Depuy, Inc. · Mar 1996
HOWMEDICA BIOABSORBABLE PIN
K955806 · Howmedica, Inc. · Feb 1996
LACTOSORB BONE PIN
K953194 · Biomet, Inc. · Oct 1995