Cleared Traditional

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (K183017) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183017 · Osteoremedies, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
267d
Days
Class 2
Risk

K183017 is an FDA 510(k) clearance for the Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on July 25, 2019 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Osteoremedies, LLC devices

Submission Details

510(k) Number K183017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2018
Decision Date July 25, 2019
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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

Mandell Horwitz Consultants, LLC
Diane Mandell Horwitz

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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K183017.
Triathlon Total Knee System-Additional Components
K190402 · Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) · Aug 2019
iTotal Identity Cruciate Retaining Knee Replacement System
K190562 · Conformis, Inc. · Aug 2019
SurgTech GENOLL Total Knee System
K191192 · Surgtech, Inc. · Aug 2019
SPAR-K Instruments (for use with Gemini SL Total Knee System)
K191755 · Waldemar Link GmbH & Co. KG · Jul 2019
Renovis A200 PS Knee System as part of the Renovis A200 Knee System
K190122 · Renovis Surgical Technologies · Jun 2019
Unity Total Knee System
K183533 · Corin U.S.A. Limited · Jun 2019