Cleared Traditional

K232251 - APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension

K232251 is an FDA 510(k) clearance for APTUS Cannulated Compression Screws Lin..., manufactured by Medartis AG. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K232251 · Medartis AG · Orthopedic device
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Nov 2023
Decision
98d
Days
Class 2
Risk

K232251 is an FDA 510(k) clearance for the APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line .... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medartis AG (Basel, CH). The FDA issued a Cleared decision on November 3, 2023 after a review of 98 days - within the typical 510(k) review window.

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 Medartis AG devices

FDA 510(k) Submission Details - K232251

510(k) Number K232251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date November 03, 2023
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K232251.
TriMed Threaded Intramedullary Nail System
K234040 · TriMed, Inc. · Jan 2024
Zimed Distal Medial Tibial Plate and Screw System
K230507 · Zimed Medikal · Jan 2024
Cannulated Screw System
K233396 · Smith & Nephew, Inc. · Dec 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
K231231 · Paragon 28, Inc. · Oct 2023
Intraosseous Fusion Device System
K231649 · Auxano Medical, LLC · Sep 2023
Accelerate Compression Screw System-Small Product Code ACC-S
K230946 · Trax Surgical · Sep 2023