Cleared Traditional

K060041 - TRIMED BONE PLATES

K060041 is the FDA 510(k) clearance for TRIMED BONE PLATES by TriMed, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K060041 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
32d
Days
Class 2
Risk

K060041 is an FDA 510(k) clearance for the TRIMED BONE 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 February 7, 2006 after a review of 32 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 TriMed, Inc. devices

Submission Details

510(k) Number K060041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date February 07, 2006
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
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 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K060041.
POLYAX LOCKED PLATING SYSTEM
K060969 · DePuy Orthopaedics, Inc. · May 2006
STRYKER PLATING SYSTEM
K060798 · Howmedica Osteonics Corp. · Apr 2006
STRYKER PLATING SYSTEM
K060514 · Howmedica Osteonics Corp. · Mar 2006
ARTHREX TENSIONLOK
K052901 · Arthrex, Inc. · Dec 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · Synthes (Usa) · Dec 2005
COLLAGEN BONE HEALING PROTECTIVE SHEET
K052041 · Collagen Matrix, Inc. · Oct 2005