Cleared Traditional

K191016 - COPAL exchange G Hip and Knee Spacers

K191016 is an FDA 510(k) clearance for COPAL exchange G Hip and Knee Spacers, manufactured by Heraeus Medical GmbH. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K191016 · Heraeus Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
198d
Days
Class 2
Risk

K191016 is an FDA 510(k) clearance for the COPAL exchange G Hip and Knee Spacers. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Heraeus Medical GmbH (Werheim, DE). The FDA issued a Cleared decision on November 1, 2019 after a review of 198 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 Heraeus Medical GmbH devices

FDA 510(k) Submission Details - K191016

510(k) Number K191016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2019
Decision Date November 01, 2019
Days to Decision 198 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 122d · This submission: 198d
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 Consultant

Alira Health
Mary McNamara-Cullinane

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 79
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K191016.
COPAL exchange G hip spacer
K220492 · Heraeus Medical GmbH · Mar 2022
Kyocera Bipolar Hip System
K200709 · Kyocera Medical Technologies, Inc. · Apr 2020
Fitmore Hip Stem
K192236 · Zimmer GmbH · Nov 2019
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