Cleared Traditional

2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors (K150715) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150715 · Tornier, Inc. · Orthopedic device
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Jul 2015
Decision
131d
Days
Class 2
Risk

K150715 is an FDA 510(k) clearance for the 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors. 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 July 28, 2015 after a review of 131 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 K150715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2015
Decision Date July 28, 2015
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 301
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K150715.
Arthrex Short Suture Anchors
K151092 · Arthrex, Inc. · Feb 2016
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
K152566 · Smith & Nephew, Inc. · Dec 2015
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
K150648 · Arthrex, Inc. · Aug 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745 · Arthrex, Inc. · Jul 2015
Arthrex FiberTak Anchors
K151230 · Arthrex, Inc. · Jun 2015
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · Arthrex, Inc. · Aug 2014