Cleared Special

K210784 - Extended HA Half Pins

K210784 is an FDA 510(k) clearance for Extended HA Half Pins, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Special 510(k) pathway after a 17-day FDA review.

K210784 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
17d
Days
Class 2
Risk

K210784 is an FDA 510(k) clearance for the Extended HA Half Pins. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on April 2, 2021 after a review of 17 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 - K210784

510(k) Number K210784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2021
Decision Date April 02, 2021
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

JDW Device Classification - Class 2, Special Controls

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

All 93
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K210784.
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
Syntec Non-Sterile Steinmann Pins System
K200933 · Syntec Scientific Corporation · May 2020
Orthopedic Fixation Pin
K191803 · Tinavi (Anhui) Medical Technologies Co., Ltd. · Apr 2020
Temporary Fixation Pins
K192768 · Eisertech, LLC · Dec 2019
K210784 · Extended HA Half Pins
Download PDF FDA Summary Smith & Nephew, Inc.