Cleared Traditional

K131354 - RENOVIS BIPOLAR HIP SYSTEM

K131354 is an FDA 510(k) clearance for RENOVIS BIPOLAR HIP SYSTEM, manufactured by Renovis Surgical Technologies, LLC. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K131354 · Renovis Surgical Technologies, LLC · Orthopedic device
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Sep 2013
Decision
132d
Days
Class 2
Risk

K131354 is an FDA 510(k) clearance for the RENOVIS BIPOLAR HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, LLC (Ashland, US). The FDA issued a Cleared decision on September 19, 2013 after a review of 132 days - within the typical 510(k) review window.

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 Renovis Surgical Technologies, LLC devices

FDA 510(k) Submission Details - K131354

510(k) Number K131354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2013
Decision Date September 19, 2013
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 85
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K131354.
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · Signature Orthopaedics Pty, Ltd. · Jan 2018
Fitmore® Hip Stem
K170072 · Zimmer GmbH · Feb 2017
U2 Bipolar Implant and 22mm Femoral Head
K152439 · United Orthopedic Corporation · Apr 2016
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
K112019 · Corentec Co., Ltd. · Oct 2011
BIOPRO POLAR HEAD
K100761 · Biopro, Inc. · Dec 2010
UNITED U2 BIPOLAR IMPLANT
K101670 · United Orthopedic Corp. · Oct 2010