Cleared Traditional

K052390 - SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION

K052390 is an FDA 510(k) clearance for SYNTHES LCP PROXIMAL TIBIA PLATES LINE ..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K052390 · Synthes (Usa) · Orthopedic device
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Oct 2005
Decision
37d
Days
Class 2
Risk

K052390 is an FDA 510(k) clearance for the SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 37 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K052390

510(k) Number K052390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2005
Decision Date October 07, 2005
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K052390.
SHOULDER NAIL PLATE
K052294 · Hand Innovations, LLC · Oct 2005
OLECRANONPLATE WITH ANGULAR STABILITY
K052368 · I.T.S. Implantat-Technologie-Systeme GmbH · Oct 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677 · Synthes (Usa) · Oct 2005
S-BONE HIP TOOL
K052538 · Orthopedic Sciences, Inc. · Oct 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614 · Arthrex, Inc. · Sep 2005
DORSAL NAIL PLATE, ANATOMICAL
K052248 · Hand Innovations, LLC · Sep 2005