Cleared Traditional

Tandry Compression Screw System (K220359) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220359 · Microware Precision Co., Ltd. · Orthopedic device
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Sep 2022
Decision
224d
Days
Class 2
Risk

K220359 is an FDA 510(k) clearance for the Tandry Compression Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Microware Precision Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on September 20, 2022 after a review of 224 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 Microware Precision Co., Ltd. devices

Submission Details

510(k) Number K220359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2022
Decision Date September 20, 2022
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 412
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K220359.
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · Treace Medical Concepts, Inc. · Nov 2022
Nextra CH Cannulated Hammertoe System
K221610 · Nextremity Solutions, Inc. · Nov 2022
CurvaFix IM System
K222505 · Curvafix, Inc. · Oct 2022
Arthrex Compression FT Pins
K220839 · Arthrex, Inc. · Sep 2022
CAPTIVATE® Compression Screws
K222409 · Globus Medical, Inc. · Sep 2022
Cannulated Screws
K213614 · Maxxion Medical, LLC · Aug 2022