Cleared Traditional

K092493 - GPC BONE PLAES AND BONE SCREW & GPC DHS...

K092493 is an FDA 510(k) clearance for GPC BONE PLAES AND BONE SCREW & GPC DHS..., manufactured by Gpc Medical, Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K092493 · Gpc Medical, Ltd. · Orthopedic device
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Mar 2010
Decision
227d
Days
Class 2
Risk

K092493 is an FDA 510(k) clearance for the GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS 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 Gpc Medical, Ltd. (Vikas Puri, New Delhi, IN). The FDA issued a Cleared decision on March 29, 2010 after a review of 227 days - an extended review 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: 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 Gpc Medical, Ltd. devices

FDA 510(k) Submission Details - K092493

510(k) Number K092493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2009
Decision Date March 29, 2010
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
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 1044
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092493.
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
K090975 · Deroyal Industries, Inc. · Apr 2010
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111 · Zimmer, Inc. · Apr 2010
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · Synthes (Usa) · Apr 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · Synthes (Usa) · Mar 2010
EDGELOCK
K093900 · Orthohelix Surgical Designs, Inc. · Feb 2010
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474 · DePuy Orthopaedics, Inc. · Feb 2010