Cleared Traditional

K974341 - MITEK BTB ABSORBABLE (PLA) CROSS PIN

K974341 is an FDA 510(k) clearance for MITEK BTB ABSORBABLE (PLA) CROSS PIN, manufactured by Mitek Products. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K974341 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
149d
Days
Class 2
Risk

K974341 is an FDA 510(k) clearance for the MITEK BTB ABSORBABLE (PLA) CROSS PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on April 16, 1998 after a review of 149 days - within the typical 510(k) review window.

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 Mitek Products devices

FDA 510(k) Submission Details - K974341

510(k) Number K974341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date April 16, 1998
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
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 171
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K974341.
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
K983121 · Syntec Scientific Corp. · Oct 1998
THE BONE TIE
K982719 · Surgicraft , Ltd. · Sep 1998
RETROGRADE PEDIATRIC NAIL
K980854 · Encore Orthopedics, Inc. · Aug 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974291 · Mitek Products · Mar 1998
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240 · Synthes (Usa) · Nov 1997
OSTEO KIRSCHNER WIRES
K971962 · Osteonics Corp. · Aug 1997