Cleared Traditional

K133235 - THREADED PEEK K-WIRE

K133235 is an FDA 510(k) clearance for THREADED PEEK K-WIRE, manufactured by Mtp Solutions, LLC. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K133235 · Mtp Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
168d
Days
Class 2
Risk

K133235 is an FDA 510(k) clearance for the THREADED PEEK K-WIRE. 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 Mtp Solutions, LLC (Logan, US). The FDA issued a Cleared decision on April 7, 2014 after a review of 168 days - an extended review 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: 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 Mtp Solutions, LLC devices

FDA 510(k) Submission Details - K133235

510(k) Number K133235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date April 07, 2014
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 K133235.
ACUMED SUTURE ANCHOR SYSTEM
K140925 · Acumed, LLC · May 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · ArthroCare Corporation · May 2014
ICONN ANSWER SUTURE ANCHOR
K132724 · Iconn Orthopedics, LLC · Apr 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · Tornier, Inc. · Apr 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