Cleared Traditional

K051155 - SOLCO 4CIS GENERAL PLATE SYSTEM

K051155 is an FDA 510(k) clearance for SOLCO 4CIS GENERAL PLATE SYSTEM, manufactured by Solco Biomedical Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K051155 · Solco Biomedical Co., Ltd. · Orthopedic device
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Jul 2005
Decision
68d
Days
Class 2
Risk

K051155 is an FDA 510(k) clearance for the SOLCO 4CIS GENERAL PLATE 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 Solco Biomedical Co., Ltd. (Bethesda, US). The FDA issued a Cleared decision on July 11, 2005 after a review of 68 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 Solco Biomedical Co., Ltd. devices

FDA 510(k) Submission Details - K051155

510(k) Number K051155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2005
Decision Date July 11, 2005
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K051155.
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681 · TriMed, Inc. · Jul 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
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PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · Smith & Nephew, Inc. · Jul 2005
MAXLOCK
K050868 · Orthohelix Surgical Designs, Inc. · May 2005
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
K051083 · Acumed, LLC · May 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · Synthes (Usa) · Apr 2005