Remedy® Shoulder Spacer— 510(k) K152267

Name: FDA 510(k) clearance K152267
Creator: U.S. Food and Drug Administration
Published: 2015-12-15

Substantially Equivalent

Osteoremedies, LLC

FDA 510(k) clearance K152267 for Remedy® Shoulder Spacer, Substantially Equivalent on 2015-12-15. Applicant: Osteoremedies, LLC. Device class: 2.

Clearance details

Applicant: Osteoremedies, LLC
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2015-08-11
Decision date: 2015-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

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K250760 — SPECTRUM GV Bone Cement2025-04-02
K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component2024-10-02
K231556 — SPECTRUM® GV Bone Cement2023-12-20

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.