Cleared Traditional

K182171 - SMV Scientific K-Wire and Pins (FDA 510(k) Clearance)

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

K182171 · Summit Medventures · Orthopedic device
Oct 2018
Decision
76d
Days
Class 2
Risk

K182171 is an FDA 510(k) clearance for the SMV Scientific K-Wire and Pins. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Summit Medventures (Austin, US). The FDA issued a Cleared decision on October 25, 2018 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K182171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date October 25, 2018
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 116d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K182171.
XT3 System
K260073 · Biodynamik, Inc. · Feb 2026
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316 · Meduloc, LLC · Oct 2025
MAVERICK Mini External Fixation System
K223112 · Smith & Nephew, Inc. · Dec 2022
MAVERICK External Fixation System
K213874 · Smith & Nephew, Inc. · Feb 2022
Steinmann Pins and Kirschner Wires
K211508 · Stryker GmbH · Oct 2021
Extended HA Half Pins
K210784 · Smith & Nephew, Inc. · Apr 2021