Cleared Traditional

K152267 - Remedy® Shoulder Spacer

K152267 is an FDA 510(k) clearance for Remedy Shoulder Spacer, manufactured by Osteoremedies, LLC. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K152267 · Osteoremedies, LLC · Orthopedic device
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Dec 2015
Decision
126d
Days
Class 2
Risk

K152267 is an FDA 510(k) clearance for the Remedy® Shoulder Spacer. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on December 15, 2015 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 888.3660 - 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

FDA 510(k) Submission Details - K152267

510(k) Number K152267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2015
Decision Date December 15, 2015
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 186
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K152267.
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