Cleared Traditional

GPC Intramedullary Nailing Systems (K143245) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143245 · Gpc Medical Limited · Orthopedic device
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Sep 2015
Decision
322d
Days
Class 2
Risk

K143245 is an FDA 510(k) clearance for the GPC Intramedullary Nailing Systems. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Gpc Medical Limited (New Delhi, IN). The FDA issued a Cleared decision on September 30, 2015 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Gpc Medical Limited devices

Submission Details

510(k) Number K143245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2014
Decision Date September 30, 2015
Days to Decision 322 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
200d slower than avg
Panel avg: 122d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 263
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K143245.
AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017
Zimmer Natural Nail System
K172114 · Zimmer, Inc. · Aug 2017
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · Zimmer, Inc. · May 2015
MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015