Cleared Traditional

K090983 - APTUS 2.0/2.3 FOUR CORNER FUSION PLATE

K090983 is the FDA 510(k) clearance for APTUS 2.0/2.3 FOUR CORNER FUSION PLATE by Medartis AG. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K090983 · Medartis AG · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
85d
Days
Class 2
Risk

K090983 is an FDA 510(k) clearance for the APTUS 2.0/2.3 FOUR CORNER FUSION PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Medartis AG (San Diego, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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

Submission Details

510(k) Number K090983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2009
Decision Date July 01, 2009
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 932
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K090983.
APTUS FOOT SYSTEM
K091479 · Medartis AG · Jul 2009
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522 · Osteomed LP · Jul 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582 · Tornier, Inc. · Jul 2009
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
K090877 · DePuy Orthopaedics, Inc. · Jun 2009
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243 · Wrightmedicaltechnologyinc · Jun 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · Smith & Nephew, Inc. · Jun 2009