Cleared Traditional

K220921 - Metal Bone Screw

K220921 is an FDA 510(k) clearance for Metal Bone Screw, manufactured by Double Medical Technology, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K220921 · Double Medical Technology, Inc. · Orthopedic device
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Dec 2022
Decision
257d
Days
Class 2
Risk

K220921 is an FDA 510(k) clearance for the Metal Bone Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on December 12, 2022 after a review of 257 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 Double Medical Technology, Inc. devices

FDA 510(k) Submission Details - K220921

510(k) Number K220921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2022
Decision Date December 12, 2022
Days to Decision 257 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
135d slower than avg
Panel avg: 122d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K220921.
BRM TOOL Screws, BIOPLAN Subtalar Implant
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Treace Medical Concepts (TMC) Hammertoe Fixation System
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K221610 · Nextremity Solutions, Inc. · Nov 2022