OsteoRemedies Hip Spacer System— 510(k) K253675

Name: FDA 510(k) clearance K253675
Creator: U.S. Food and Drug Administration
Published: 2025-12-23

Substantially Equivalent

Osteoremedies, LLC

FDA 510(k) clearance K253675 for OsteoRemedies Hip Spacer System, Substantially Equivalent on 2025-12-23. Applicant: Osteoremedies, LLC. Device class: 2.

Clearance details

Applicant: Osteoremedies, LLC
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2025-11-21
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Germantown, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWL

view all

K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup2026-07-24
K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12
K234028 — COPAL® exchange G hip spacer; COPAL® G+V2024-02-15

More clearances from Osteoremedies, LLC

view all

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
K223650 — REMEDY Stemmed Knee Spacer2023-01-05
K192995 — OsteoRemedies Hip Spacer System2020-01-10

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.