Cleared Traditional

K191803 - Orthopedic Fixation Pin

K191803 is an FDA 510(k) clearance for Orthopedic Fixation Pin, manufactured by Tinavi (Anhui) Medical Technologies Co., Ltd.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K191803 · Tinavi (Anhui) Medical Technologies Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
286d
Days
Class 2
Risk

K191803 is an FDA 510(k) clearance for the Orthopedic Fixation Pin. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Tinavi (Anhui) Medical Technologies Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on April 14, 2020 after a review of 286 days - an extended review 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: 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 Tinavi (Anhui) Medical Technologies Co., Ltd. devices

FDA 510(k) Submission Details - K191803

510(k) Number K191803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date April 14, 2020
Days to Decision 286 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
164d slower than avg
Panel avg: 122d · This submission: 286d
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 Peers - JDW Pin, Fixation, Threaded

All 82
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K191803.
Steinmann Pins and Kirschner Wires
K211508 · Stryker GmbH · Oct 2021
Extended HA Half Pins
K210784 · Smith & Nephew, Inc. · Apr 2021
Syntec Non-Sterile Steinmann Pins System
K200933 · Syntec Scientific Corporation · May 2020
Temporary Fixation Pins
K192768 · Eisertech, LLC · Dec 2019
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018
Ultima HA Coated Half Pins and Wire
K163487 · Vilex IN Tennessee, Inc. · Feb 2017