Cleared Special

LTJ Screws and Washer (K210268) - FDA 510(k) Clearance

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

K210268 · Azurmeds, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
25d
Days
Class 2
Risk

K210268 is an FDA 510(k) clearance for the LTJ Screws and Washer. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Azurmeds, Inc. (Chicago, US). The FDA issued a Cleared decision on February 26, 2021 after a review of 25 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 Azurmeds, Inc. devices

Submission Details

510(k) Number K210268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date February 26, 2021
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 417
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K210268.
Axis Charcot Fixation System
K211261 · Extremity Medical, LLC · May 2021
DART-FIRE EDGE Cannulated Screw System
K203228 · Wright Medical · May 2021
Cannulated Fasteners and Nuts
K210754 · OsteoCentric Technologies · Apr 2021
Dynanail Mini Hybrid
K203381 · MedShape, Inc. · Jan 2021
Inion CompressOn Screw
K203105 · Inion OY · Jan 2021
Fixone Biocomposite Interference Screw
K193497 · Aju Pharm Co., Ltd. · Jan 2021