Cleared Traditional

K173556 - Injection Screw

K173556 is the FDA 510(k) clearance for Injection Screw by Biedermann Medtech, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K173556 · Biedermann Medtech, Inc. · Orthopedic device
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Jul 2018
Decision
238d
Days
Class 2
Risk

K173556 is an FDA 510(k) clearance for the Injection Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biedermann Medtech, Inc. (Miami, US). The FDA issued a Cleared decision on July 13, 2018 after a review of 238 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 Biedermann Medtech, Inc. devices

Submission Details

510(k) Number K173556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2017
Decision Date July 13, 2018
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
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 567
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K173556.
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