Cleared Traditional

K210198 - GPC 2.4mm Variable Angle Locking Twon C...

K210198 is an FDA 510(k) clearance for GPC 2.4mm Variable Angle Locking Twon C..., manufactured by Gpc Medical Limited. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K210198 · Gpc Medical Limited · Orthopedic device
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Jan 2022
Decision
347d
Days
Class 2
Risk

K210198 is an FDA 510(k) clearance for the GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 he.... 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 Limited (New Delhi, IN). The FDA issued a Cleared decision on January 7, 2022 after a review of 347 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 Gpc Medical Limited devices

FDA 510(k) Submission Details - K210198

510(k) Number K210198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2021
Decision Date January 07, 2022
Days to Decision 347 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
225d slower than avg
Panel avg: 122d · This submission: 347d
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 1022
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K210198.
ANTHEM® Fracture System
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K202803 · Newclip Technics · Dec 2021
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K213069 · In2bones USA, LLC · Dec 2021