Cleared Traditional

K050681 - OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES

K050681 is an FDA 510(k) clearance for OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM..., manufactured by TriMed, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K050681 · TriMed, Inc. · Orthopedic device
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Jul 2005
Decision
133d
Days
Class 2
Risk

K050681 is an FDA 510(k) clearance for the OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on July 27, 2005 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all TriMed, Inc. devices

FDA 510(k) Submission Details - K050681

510(k) Number K050681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2005
Decision Date July 27, 2005
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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 1216
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K050681.
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
K050655 · Kapp Surgical Instrument, Inc. · Aug 2005
MONDEAL CONTOUR HO SYSTEM
K050657 · Kapp Surgical Instrument, Inc. · Aug 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · Wrightmedicaltechnologyinc · Aug 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410 · Acumed, LLC · Jul 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · Smith & Nephew, Inc. · Jul 2005
SOLCO 4CIS GENERAL PLATE SYSTEM
K051155 · Solco Biomedical Co., Ltd. · Jul 2005