Cleared Traditional

K192768 - Temporary Fixation Pins

K192768 is an FDA 510(k) clearance for Temporary Fixation Pins, manufactured by Eisertech, LLC. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K192768 · Eisertech, LLC · Orthopedic device
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Dec 2019
Decision
87d
Days
Class 2
Risk

K192768 is an FDA 510(k) clearance for the Temporary Fixation Pins. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Eisertech, LLC (San Diego, US). The FDA issued a Cleared decision on December 26, 2019 after a review of 87 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.

View all Eisertech, LLC devices

FDA 510(k) Submission Details - K192768

510(k) Number K192768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date December 26, 2019
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Mrc-X, LLC
Dawn Norman

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 79
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K192768.
Extended HA Half Pins
K210784 · Smith & Nephew, Inc. · Apr 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
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · Vilex, Inc. · Jul 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · Genossis, LLC · May 2014