Cleared Traditional

K150871 - ForeFoot STP System

K150871 is an FDA 510(k) clearance for ForeFoot STP System, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K150871 · Tornier, Inc. · Orthopedic device
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Aug 2015
Decision
125d
Days
Class 2
Risk

K150871 is an FDA 510(k) clearance for the ForeFoot STP System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tornier, Inc. (Medina, US). The FDA issued a Cleared decision on August 4, 2015 after a review of 125 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

FDA 510(k) Submission Details - K150871

510(k) Number K150871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2015
Decision Date August 04, 2015
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 958
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150871.
CrossTIE Intraosseous Fixation System
K151270 · Crossroads Extremity Systems, LLC · Sep 2015
PRO-TOE Hammertoe Fixation System
K151838 · Wrightmedicaltechnologyinc · Sep 2015
Synchro-Medical TIGER TRACK Screw System
K151241 · Synchro Medical · Aug 2015
N-Force Fixation System
K151146 · Innovision, Inc. · Jul 2015
OsteoMed Cannulated Screw System
K151021 · Osteomed Corp. · Jul 2015
Monster Screw System
K151418 · Paragon 28 · Jul 2015