Cleared Traditional

K152439 - U2 Bipolar Implant and 22mm Femoral Head

K152439 is an FDA 510(k) clearance for U2 Bipolar Implant and 22mm Femoral Head, manufactured by United Orthopedic Corporation. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K152439 · United Orthopedic Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
224d
Days
Class 2
Risk

K152439 is an FDA 510(k) clearance for the U2 Bipolar Implant and 22mm Femoral Head. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on April 7, 2016 after a review of 224 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 United Orthopedic Corporation devices

FDA 510(k) Submission Details - K152439

510(k) Number K152439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date April 07, 2016
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
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 K152439.
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
Fitmore® Hip Stem
K170072 · Zimmer GmbH · Feb 2017
Klassic BiPolar System
K143113 · Total Joint Orthopedics · Jan 2015
RING-LOK MODULAR BIPOLAR SYSTEM
K132539 · Implants International, Ltd. · Feb 2014
RENOVIS BIPOLAR HIP SYSTEM
K131354 · Renovis Surgical Technologies, LLC · Sep 2013