Cleared Traditional

K110473 - NANOTACK SUTURE ANCHOR 1.4MM

K110473 is an FDA 510(k) clearance for NANOTACK SUTURE ANCHOR 1.4MM, manufactured by Pivot Medical. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K110473 · Pivot Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
96d
Days
Class 2
Risk

K110473 is an FDA 510(k) clearance for the NANOTACK SUTURE ANCHOR 1.4MM. 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 Pivot Medical (Sunnyvale, US). The FDA issued a Cleared decision on May 25, 2011 after a review of 96 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 Pivot Medical devices

FDA 510(k) Submission Details - K110473

510(k) Number K110473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2011
Decision Date May 25, 2011
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 K110473.
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
K111471 · Medshape Solutions, Inc. · Jun 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · Tornier, Inc. · Jun 2011
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
K110781 · Arthrocare Corp. · May 2011
ROG KNOTLESS SUTURE ANCHOR
K110230 · Rog Sports Medicine, Inc. · May 2011
ROG SUTURE ANCHOR 5.5MM, 2.9MM
K110229 · Rog Sports Medicine, Inc. · May 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · Tornier, Inc. · Apr 2011