Cleared Special

K140970 - ONE-PIECE PEEK FUSION IMPLANT

K140970 is an FDA 510(k) clearance for ONE-PIECE PEEK FUSION IMPLANT, manufactured by Mtp Solutions, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 27-day FDA review.

K140970 · Mtp Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
27d
Days
Class 2
Risk

K140970 is an FDA 510(k) clearance for the ONE-PIECE 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 May 13, 2014 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140970

510(k) Number K140970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2014
Decision Date May 13, 2014
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K140970.
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · Wrightmedicaltechnologyinc · May 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · Wrightmedicaltechnologyinc · May 2014
SALVATION OSTEOPENIC SCREW
K140408 · Wrightmedicaltechnologyinc · May 2014
STABILIZATION SCREW
K131920 · In2bones Sas · May 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911 · In2bones Sas · Apr 2014
PEEK FUSION IMPLANT
K133515 · Mtp Solutions, LLC · Mar 2014
K140970 · ONE-PIECE PEEK FUSION IMPLANT
Download PDF FDA Summary Mtp Solutions, LLC