Cleared Traditional

K133777 - TORNIER INSITE(TM) FT PEEK KNOTLESS SUT...

K133777 is the FDA 510(k) clearance for TORNIER INSITE(TM) FT PEEK KNOTLESS SUT... by Tornier, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K133777 · Tornier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
113d
Days
Class 2
Risk

K133777 is an FDA 510(k) clearance for the TORNIER INSITE(TM) FT PEEK KNOTLESS 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 Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 113 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 Tornier, Inc. devices

Submission Details

510(k) Number K133777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2013
Decision Date April 04, 2014
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 416
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K133777.
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · Smith & Nephew, Inc. · Jul 2014
ACUMED SUTURE ANCHOR SYSTEM
K140925 · Acumed, LLC · May 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · ArthroCare Corporation · May 2014
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
K133606 · ArthroCare Corporation · Apr 2014
ACUMED SUTURE ANCHOR SYSTEM
K133469 · Acumed, LLC · Mar 2014
ICONIX ALL SUTURE ANCHORS
K133671 · Stryker Corp. · Feb 2014