Cleared Traditional

K133460 - APTUS CANNULATED COMPRESSION SCREWS

K133460 is an FDA 510(k) clearance for APTUS CANNULATED COMPRESSION SCREWS, 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 36-day FDA review.

K133460 · Medartis AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
36d
Days
Class 2
Risk

K133460 is an FDA 510(k) clearance for the APTUS CANNULATED COMPRESSION SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medartis AG (San Diego, US). The FDA issued a Cleared decision on December 18, 2013 after a review of 36 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K133460

510(k) Number K133460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date December 18, 2013
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 122d · This submission: 36d
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 968
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K133460.
OSTEOMED EXTREMIFUSE SYSTEM
K140283 · Osteomed · Feb 2014
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
K130613 · Laura Cattabriga · Jan 2014
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
K133440 · Stryker Trauma AG · Dec 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · Synthes USA Products, LLC · Dec 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035 · Normed Medizin-Technik GmbH · Dec 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591 · Pega Medical, Inc. · Nov 2013