Cleared Traditional

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System (K202589) - FDA 510(k) Clearance

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

K202589 · Medartis AG · General Hospital
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Nov 2020
Decision
59d
Days
Class 2
Risk

K202589 is an FDA 510(k) clearance for the APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Scre.... 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 6, 2020 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 888.3040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medartis AG devices

Submission Details

510(k) Number K202589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2020
Decision Date November 06, 2020
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
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 General Hospital devices follow this clearance model.

Regulatory Consultant

PaxMed International, LLC
Lauren M. Wessell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1058
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K202589.
VEOFIX Snap Off Screw
K253108 · Steps Ortho · Jun 2026
CoLink® & CoLag® Non-Sterile Screws
K261154 · In2bones USA, LLC · May 2026
TriMed Compression Screws
K261241 · TriMed, Inc. · May 2026
Arthrex Beaming System
K254215 · Arthrex, Inc. · May 2026
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077 · OSSIO , Ltd. · May 2026
TITAN Nail
K260934 · Medartis AG · Apr 2026