Cleared Traditional

K093897 - SMITH & NEPHEW FOOTPRINT ULTRA PK SUTUR...

K093897 is an FDA 510(k) clearance for SMITH & NEPHEW FOOTPRINT ULTRA PK SUTUR..., manufactured by Smith & Nephew Inc., Endoscopy Div.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K093897 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
76d
Days
Class 2
Risk

K093897 is an FDA 510(k) clearance for the SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR. 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 Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on March 4, 2010 after a review of 76 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 Smith & Nephew Inc., Endoscopy Div. devices

FDA 510(k) Submission Details - K093897

510(k) Number K093897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date March 04, 2010
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 439
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