Cleared Traditional

K973009 - MITEK NON ABSORBABLE POLYPROPYLENE H FIX

K973009 is the FDA 510(k) clearance for MITEK NON ABSORBABLE POLYPROPYLENE H FIX by Mitek Products. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K973009 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF)
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Nov 1997
Decision
89d
Days
Class 2
Risk

K973009 is an FDA 510(k) clearance for the MITEK NON ABSORBABLE POLYPROPYLENE H FIX. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 89 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 Mitek Products devices

Submission Details

510(k) Number K973009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date November 10, 1997
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K973009.
HARPOON SUTURE ANCHORS
K973775 · Biomet, Inc. · Apr 1998
ACUMED SUTURE ANCHOR
K980103 · Acu Med, Inc. · Mar 1998
CRANIOFACIAL ANCHORS
K974136 · Biomet, Inc. · Jan 1998
CSCO FOREHEAD FIXATION SYSTEM
K963502 · Howmedica Corp. · Oct 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723 · Arthrex, Inc. · Jul 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · American Medical Systems, Inc. · Jul 1997