Cleared Traditional

K971144 - MULTITAK SS SUTURE SYSTEM

K971144 is the FDA 510(k) clearance for MULTITAK SS SUTURE SYSTEM by Bonutti Research. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K971144 · Bonutti Research · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
89d
Days
Class 2
Risk

K971144 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 June 25, 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 Bonutti Research devices

Submission Details

510(k) Number K971144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date June 25, 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 K971144.
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · American Medical Systems, Inc. · Jul 1997
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282 · Wrightmedicaltechnologyinc · Jun 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · Boston Scientific Corp · Jun 1997
PRELOADED SOFT TISSUE ANCHOR
K963932 · Linvatec Corp. · Jun 1997
ANSPACH SUTURE ANCHOR
K965069 · The Anspach Effort, Inc. · Feb 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786 · Wrightmedicaltechnologyinc · Feb 1997