Cleared Traditional

K203605 - SteriTrak

K203605 is an FDA 510(k) clearance for SteriTrak, manufactured by Arbutus Medical, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K203605 · Arbutus Medical, Inc. · Orthopedic device
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Apr 2021
Decision
134d
Days
Class 2
Risk

K203605 is an FDA 510(k) clearance for the SteriTrak. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Arbutus Medical, Inc. (Vancouver, CA). The FDA issued a Cleared decision on April 23, 2021 after a review of 134 days - within the typical 510(k) review window.

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 Arbutus Medical, Inc. devices

FDA 510(k) Submission Details - K203605

510(k) Number K203605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2020
Decision Date April 23, 2021
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 46
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K203605.
Anjon Bremer Halo System
K193256 · Anjon Holdings, LLC · Mar 2020
DigiFix Sterile Kit
K192465 · Virak Orthopedics, LLC · Oct 2019
PIP Fix
K181192 · Hand Biomechanics Lab, Inc. · Oct 2018
Anjon Bremer Halo System
K171863 · Anjon Holdings, LLC · Mar 2018
Medline ReNewal Reprocessed Stryker External Fixation Devices
K163028 · Surgical Instrument Service and Savings, Inc. · Dec 2016
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
K102885 · Stryker Corp. · Jan 2011