Cleared Traditional

K183104 - Mini Cannulated Headed and Headless Screw Set

K183104 is an FDA 510(k) clearance for Mini Cannulated Headed and Headless Scr..., manufactured by Stryker GmbH. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K183104 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2019
Decision
214d
Days
Class 2
Risk

K183104 is an FDA 510(k) clearance for the Mini Cannulated Headed and Headless Screw Set. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on June 10, 2019 after a review of 214 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 Stryker GmbH devices

FDA 510(k) Submission Details - K183104

510(k) Number K183104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2018
Decision Date June 10, 2019
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
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 934
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K183104.
ActivOrtho Continuous Compression Screw System
K191817 · Activortho, Inc. · Jul 2019
OrthoPediatrics Cannulated Screw System
K190324 · OrthoPediatrics Corp. · Jul 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
K183363 · Treace Medical Concepts, Inc. · Jun 2019
InCore® Lapidus Sterile Kits
K190231 · Nextremity Solutions, Inc. · May 2019
IntraLock Lapidus System
K182342 · Fusion Orthopedics, LLC · May 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · Arthrex, Inc. · Apr 2019