Cleared Traditional

K191297 - iNSitu Bipolar Hip System

K191297 is the FDA 510(k) clearance for iNSitu Bipolar Hip System by Theken Companies, LLC. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K191297 · Theken Companies, LLC · Orthopedic device
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Sep 2019
Decision
126d
Days
Class 2
Risk

K191297 is an FDA 510(k) clearance for the iNSitu Bipolar Hip System. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Theken Companies, LLC (Akron, US). The FDA issued a Cleared decision on September 17, 2019 after a review of 126 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 Theken Companies, LLC devices

Submission Details

510(k) Number K191297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date September 17, 2019
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Biovera
Bob Poggie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 73
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K191297.
Kyocera Bipolar Hip System
K200709 · Kyocera Medical Technologies, Inc. · Apr 2020
Fitmore Hip Stem
K192236 · Zimmer GmbH · Nov 2019
COPAL exchange G Hip and Knee Spacers
K191016 · Heraeus Medical GmbH · Nov 2019
Implantcast ic-Bipolar Head System
K191569 · Implantcast GmbH · Aug 2019
Corin BiPolar-i
K183114 · Corin U.S.A. Limited · Jun 2019
SurgTech Bipolar Head System
K173455 · Surgtech, Inc. · Jun 2018