Cleared Traditional

Remedy Acetabular Cup (K173967) - FDA 510(k) Clearance

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

K173967 · Osteoremedies, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
55d
Days
Class 2
Risk

K173967 is an FDA 510(k) clearance for the Remedy Acetabular Cup. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on February 22, 2018 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteoremedies, LLC devices

Submission Details

510(k) Number K173967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2017
Decision Date February 22, 2018
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 51
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K173967.
OsteoRemedies Hip Spacer System
K192995 · Osteoremedies, LLC · Jan 2020
REMEDY Acetabular Cup
K191981 · Osteoremedies, LLC · Aug 2019
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
K172906 · Osteoremedies, LLC · Aug 2018
CORIN ADAPTOR SLEEVE
K071471 · Howmedica Osteonics Corp. · Sep 2007
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · Smith & Nephew, Inc. · Sep 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006