Cleared Traditional

K102785 - TRIMED RADIOCARPAL FUSION SYSTEM

K102785 is the FDA 510(k) clearance for TRIMED RADIOCARPAL FUSION SYSTEM by TriMed, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K102785 · TriMed, Inc. · Orthopedic device
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Aug 2011
Decision
326d
Days
Class 2
Risk

K102785 is an FDA 510(k) clearance for the TRIMED RADIOCARPAL FUSION 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 TriMed, Inc. (Saugus, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K102785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2010
Decision Date August 19, 2011
Days to Decision 326 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
204d slower than avg
Panel avg: 122d · This submission: 326d
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 K102785.
TRIMED CLAVICLE FIXATION SYSTEM
K112509 · TriMed, Inc. · Nov 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174 · Zimmer, Inc. · Oct 2011
EASYLOCK OSTEOSYSTEM
K111266 · TriMed, Inc. · Oct 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432 · Wrightmedicaltechnologyinc · Aug 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · Synthes (Usa) · Aug 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · OrthoPediatrics Corp. · Aug 2011