Cleared Traditional

K173455 - SurgTech Bipolar Head System

K173455 is the FDA 510(k) clearance for SurgTech Bipolar Head System by Surgtech, Inc.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K173455 · Surgtech, Inc. · Orthopedic device
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Jun 2018
Decision
219d
Days
Class 2
Risk

K173455 is an FDA 510(k) clearance for the SurgTech Bipolar Head System. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Surgtech, Inc. (Westlake, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 219 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 Surgtech, Inc. devices

Submission Details

510(k) Number K173455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2017
Decision Date June 14, 2018
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
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

Orchid Design
Kellen Hills

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 K173455.
iNSitu Bipolar Hip System
K191297 · Theken Companies, LLC · Sep 2019
Implantcast ic-Bipolar Head System
K191569 · Implantcast GmbH · Aug 2019
Corin BiPolar-i
K183114 · Corin U.S.A. Limited · Jun 2019
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