Cleared Traditional

K183114 - Corin BiPolar-i

K183114 is an FDA 510(k) clearance for Corin BiPolar-i, manufactured by Corin U.S.A. Limited. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K183114 · Corin U.S.A. Limited · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2019
Decision
208d
Days
Class 2
Risk

K183114 is an FDA 510(k) clearance for the Corin BiPolar-i. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on June 5, 2019 after a review of 208 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 Corin U.S.A. Limited devices

FDA 510(k) Submission Details - K183114

510(k) Number K183114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2018
Decision Date June 05, 2019
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 91
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K183114.
COPAL exchange G Hip and Knee Spacers
K191016 · Heraeus Medical GmbH · Nov 2019
iNSitu Bipolar Hip System
K191297 · Theken Companies, LLC · Sep 2019
Implantcast ic-Bipolar Head System
K191569 · Implantcast GmbH · Aug 2019
SurgTech Bipolar Head System
K173455 · Surgtech, Inc. · Jun 2018
ELEOS™ Bipolar Acetabular System
K180130 · Onkos Surgical, Inc. · Feb 2018
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · Signature Orthopaedics Pty, Ltd. · Jan 2018