Cleared Traditional

K051567 - APTUS TITANIUM OSTEOSYNTHESIS SYSTEM

K051567 is an FDA 510(k) clearance for APTUS TITANIUM OSTEOSYNTHESIS SYSTEM, manufactured by Medartis, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K051567 · Medartis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
70d
Days
Class 2
Risk

K051567 is an FDA 510(k) clearance for the APTUS TITANIUM OSTEOSYNTHESIS SYSTEM. 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, Inc. (San Diego, US). The FDA issued a Cleared decision on August 23, 2005 after a review of 70 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, Inc. devices

FDA 510(k) Submission Details - K051567

510(k) Number K051567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date August 23, 2005
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1101
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K051567.
B-BOP PLATE
K052152 · New Deal, S.A. · Sep 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986 · Synthes (Usa) · Sep 2005
MIOT PLATING SYSTEM
K051945 · Orthofix Srl · Sep 2005
CHARLOTTE COMPRESSION PLATE
K051908 · Wrightmedicaltechnologyinc · Aug 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · Wrightmedicaltechnologyinc · Aug 2005
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681 · TriMed, Inc. · Jul 2005