Cleared Traditional

K133515 - PEEK FUSION IMPLANT

K133515 is an FDA 510(k) clearance for PEEK FUSION IMPLANT, manufactured by Mtp Solutions, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K133515 · Mtp Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
133d
Days
Class 2
Risk

K133515 is an FDA 510(k) clearance for the PEEK FUSION IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mtp Solutions, LLC (Logan, US). The FDA issued a Cleared decision on March 28, 2014 after a review of 133 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 Mtp Solutions, LLC devices

FDA 510(k) Submission Details - K133515

510(k) Number K133515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2013
Decision Date March 28, 2014
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K133515.
ONE-PIECE PEEK FUSION IMPLANT
K140970 · Mtp Solutions, LLC · May 2014
STABILIZATION SCREW
K131920 · In2bones Sas · May 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911 · In2bones Sas · Apr 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · Extremity Medical, LLC · Mar 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · Tyber Medical, LLC · Mar 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713 · Wrightmedicaltechnologyinc · Mar 2014