Cleared Special

Syntec Non-Sterile Steinmann Pins System (K200933) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200933 · Syntec Scientific Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
28d
Days
Class 2
Risk

K200933 is an FDA 510(k) clearance for the Syntec Non-Sterile Steinmann Pins System. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Syntec Scientific Corporation (Chang Hua, TW). The FDA issued a Cleared decision on May 5, 2020 after a review of 28 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.

View all Syntec Scientific Corporation devices

Submission Details

510(k) Number K200933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2020
Decision Date May 05, 2020
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Syntec Scientific Corporation - Taipei Office
Nicole Tseng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDW Pin, Fixation, Threaded

All 41
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K200933.
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
Orthopedic Fixation Pin
K191803 · Tinavi (Anhui) Medical Technologies Co., Ltd. · Apr 2020
Temporary Fixation Pins
K192768 · Eisertech, LLC · Dec 2019
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018