Cleared Traditional

K973015 - MULTITAK SS SUTURE SYSTEM

K973015 is an FDA 510(k) clearance for MULTITAK SS SUTURE SYSTEM, manufactured by Bonutti Research. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K973015 · Bonutti Research · Orthopedic device
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Oct 1997
Decision
57d
Days
Class 2
Risk

K973015 is an FDA 510(k) clearance for the MULTITAK SS SUTURE SYSTEM. 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 Bonutti Research (Effingham, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 57 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 Bonutti Research devices

FDA 510(k) Submission Details - K973015

510(k) Number K973015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date October 09, 1997
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

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 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K973015.
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · Mitek Products · Nov 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · Howmedica Corp. · Oct 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622 · Influence, Inc. · Oct 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · Innovasive Devices, Inc. · Sep 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · Innovasive Devices, Inc. · Aug 1997
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971922 · Innovasive Devices, Inc. · Aug 1997