Cleared Traditional

K202589 - APTUS Cannulated Compression Screws

K202589 is the FDA 510(k) clearance for APTUS Cannulated Compression Screws by Medartis AG. It is a Class 2 General Hospital device (product code HWC) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

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 552
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K202589.
WishBone Medical Plate and Screw System
K203467 · Wishbone Medical, Inc. · Dec 2020
CREED™ Cannulated Screws
K200291 · Glw Medical, Inc. · Dec 2020
Monster Screw System
K203011 · Paragon 28, Inc. · Nov 2020
GEO Bone Screw System
K202817 · Gramercy Extremity Orthopedics, LLC · Oct 2020
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
K202680 · Osteomed, LLC · Oct 2020
Responsive Arthroscopy Interference Screw System
K202569 · Responsive Arthroscopy, LLC · Sep 2020